9 Pharmaceutical jobs in Manati
Manager, Pharmaceutical Repackaging Stability Program
00918 San Juan, Puerto Rico
Cardinal Health
Posted 7 days ago
Job Viewed
Job Description
**_What Quality Assurance contributes to Cardinal Health_**
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.
**_Job Summary_**
This role is responsible for the oversight and management of the stability program for repackaged pharmaceutical products, ensuring compliance with current Good Manufacturing Practices (cGMP) and relevant regulatory guidelines. This role demands a strong understanding of stability testing methodologies, quality control principles, data analysis, and a proven track record in a GMP environment. This role helps ensure the quality, safety, and efficacy of products through the development, implementation, and maintenance of robust stability protocols, testing procedures, and quality systems. The manager will lead cross functional collaborations and possess exceptional communication and interpersonal skills to effectively collaborate with internal business partners and external stakeholders.
**_Responsibilities_**
+ **Program Oversight:** Develop, maintain, and oversee the stability program and related studies, ensuring alignment with cGMP requirements and industry best practices.
+ **Repackaged Product Stability:** Manage the stability program for all repackaged products, ensuring appropriate stability studies are designed and executed to support the shelf life and storage conditions of these products. This includes developing specifications, protocols and acceptance criteria for repackaged products.
+ **Documentation:** Develop, review, and approve stability protocols for repackaged pharmaceutical products in accordance with regulatory requirements and industry standards. Generate, review, and revise Standard Operating Procedures (SOPs), protocols, reports, and other relevant documentation to ensure compliance with cGMP and regulatory standards.
+ **Contract Laboratory Management:** Manage third party laboratories executing stability protocols, including oversight of data integrity, adherence to cGMP and performance monitoring.
+ **Stability Sample Management:** Oversee the shipment of stability samples from repackaging facilities to laboratories and ensuring appropriate sample submission documentation.
+ **Data Analysis and Trending:** Perform in-depth stability data trending analysis, identify data anomalies, and compile comprehensive reports, ensuring data integrity and compliance with cGMP. Manage the preparation and review of Annual Product Reviews to identify trends, assess product performance, and ensure continued product quality.
+ **Container-Closure Selection:** Oversee the selection and qualification of appropriate container-closure systems (specifically foil and film for unit dose blisters) to ensure product integrity and stability throughout shelf-life.
+ **OOS/OOT Investigations:** Lead and conduct thorough Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations related to stability data, including root cause analysis, hypothesis testing, and implementation of corrective and preventive actions (CAPAs) to prevent recurrence. Ensure investigations are initiated and completed in a timely manner, adhering to established timelines and regulatory expectations. Ensure investigations are well-documented, scientifically sound, and compliant with cGMP requirements. Serve as the primary point of contact for escalating quality issues and concerns to the drug manufacturer, ensuring timely resolution and communication.
+ **Method Transfer/Verification:** Responsible for all method transfer and method verification activities related to stability testing, ensuring successful implementation and validation of analytical methods across multiple laboratories. This includes protocol development, data review, and troubleshooting.
+ **Budget Management:** Develop and manage the budget for stability testing activities, ensuring cost-effective utilization of resources.
+ **Risk Management:** Conduct risk assessments related to stability and implement appropriate mitigation strategies.
+ **Team Leadership:** Lead, mentor, and develop a team of quality professionals. Provide clear direction, set performance expectations, and provide regular feedback. Foster a collaborative and high-performing team environment. Effectively delegate tasks and responsibilities to team members, ensuring appropriate workload distribution and skill development opportunities.
+ **Cross-Functional Collaboration:** Collaborate with project managers, Inventory Management, Sourcing, and other Quality Assurance team members to ensure seamless execution of stability studies and related activities.
+ **Communication:** Effectively communicate with internal and external stakeholders, providing updates on stability study progress, addressing technical issues, and ensuring alignment with project timelines and cGMP requirements. Ensure timely responses to inquiries and requests for information.
+ **GMP Compliance:** Ensure all stability activities are performed in compliance with cGMP regulations, company policies, and industry standards. Participate in internal and external audits, and implement corrective actions as necessary.
**_Qualifications_**
+ Bachelor's degree in a relevant scientific field preferred (e.g., Chemistry).
+ Minimum 8 years of experience in a GMP-regulated pharmaceutical quality oversight environment, with a focus on stability testing and data analysis preferred.
+ Prior experience in pharmaceutical repackaging, contract manufacturing, or generics is a plus.
+ In-depth knowledge of FDA regulations, ICH guidelines, USP monographs, and other relevant regulatory requirements related to stability testing and cGMP compliance.
+ Proficiency with Laboratory Information Management Systems (LIMS), electronic quality systems, statistical software and other relevant software applications used for data analysis and reporting, along with good documentation practices.
+ Demonstrated expertise in conducting OOS/OOT investigations, including root cause analysis and CAPA implementation. Experience managing investigations to meet established timelines.
+ Demonstrated expertise with inspections and audits from customers and regulators through active engagement and critical participation.
+ Experience with method transfer and method verification processes.
+ Experience in developing container closure strategy to ensure suitable packaging systems to achieve desirable outcomes is a plus.
+ Proven ability to lead and motivate a team, driving a culture of compliance, quality, and continuous improvement while balancing business goals and operational efficiency.
+ Drives core culture principles of accountability and ownership throughout the team and peers.
+ Experience in utilizing risk-based assessment methodologies that leverage mechanistic insights that may impact the quality and efficacy of drug product stability.
+ Strong problem-solving, analytical, and critical thinking skills, with the ability to identify and resolve complex issues related to stability testing and cGMP compliance in real time.
+ Excellent attention to detail, organizational skills, and the ability to manage multiple projects simultaneously.
+ Exceptional written and verbal communication skills, with the ability to effectively communicate complex scientific information to both technical and non-technical audiences, and to build strong relationships with internal and external business partners.
+ Effectively communicates and collaborates with senior leaders in the organization clearly and succinctly, taking into account corporate priorities and the goals of different departments and groups.
+ Ability to onboard and engage with external customers and vendors and forge strong working relationships to deliver excellent customer experience.
+ Thorough understanding of cGMP principles and practices, including data integrity requirements.
**_What is expected of you and others at this level_**
+ Manages department operations and supervises professional employees, front line supervisors and/or business support staff
+ Participates in the development of policies and procedures to achieve specific goals
+ Ensures employees operate within guidelines
+ Decisions have a short term impact on work processes, outcomes and customers
+ Interacts with subordinates, peers, customers, and suppliers at various management levels; may interact with senior management
+ Interactions normally involve resolution of issues related to operations and/or projects
+ Gains consensus from various parties involved
**Anticipated salary range:** $105,500 - $145,700
**Bonus eligible:** Yes
**Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with myFlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
**Application window anticipated to close:** 11/30/2025 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.
**_Job Summary_**
This role is responsible for the oversight and management of the stability program for repackaged pharmaceutical products, ensuring compliance with current Good Manufacturing Practices (cGMP) and relevant regulatory guidelines. This role demands a strong understanding of stability testing methodologies, quality control principles, data analysis, and a proven track record in a GMP environment. This role helps ensure the quality, safety, and efficacy of products through the development, implementation, and maintenance of robust stability protocols, testing procedures, and quality systems. The manager will lead cross functional collaborations and possess exceptional communication and interpersonal skills to effectively collaborate with internal business partners and external stakeholders.
**_Responsibilities_**
+ **Program Oversight:** Develop, maintain, and oversee the stability program and related studies, ensuring alignment with cGMP requirements and industry best practices.
+ **Repackaged Product Stability:** Manage the stability program for all repackaged products, ensuring appropriate stability studies are designed and executed to support the shelf life and storage conditions of these products. This includes developing specifications, protocols and acceptance criteria for repackaged products.
+ **Documentation:** Develop, review, and approve stability protocols for repackaged pharmaceutical products in accordance with regulatory requirements and industry standards. Generate, review, and revise Standard Operating Procedures (SOPs), protocols, reports, and other relevant documentation to ensure compliance with cGMP and regulatory standards.
+ **Contract Laboratory Management:** Manage third party laboratories executing stability protocols, including oversight of data integrity, adherence to cGMP and performance monitoring.
+ **Stability Sample Management:** Oversee the shipment of stability samples from repackaging facilities to laboratories and ensuring appropriate sample submission documentation.
+ **Data Analysis and Trending:** Perform in-depth stability data trending analysis, identify data anomalies, and compile comprehensive reports, ensuring data integrity and compliance with cGMP. Manage the preparation and review of Annual Product Reviews to identify trends, assess product performance, and ensure continued product quality.
+ **Container-Closure Selection:** Oversee the selection and qualification of appropriate container-closure systems (specifically foil and film for unit dose blisters) to ensure product integrity and stability throughout shelf-life.
+ **OOS/OOT Investigations:** Lead and conduct thorough Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations related to stability data, including root cause analysis, hypothesis testing, and implementation of corrective and preventive actions (CAPAs) to prevent recurrence. Ensure investigations are initiated and completed in a timely manner, adhering to established timelines and regulatory expectations. Ensure investigations are well-documented, scientifically sound, and compliant with cGMP requirements. Serve as the primary point of contact for escalating quality issues and concerns to the drug manufacturer, ensuring timely resolution and communication.
+ **Method Transfer/Verification:** Responsible for all method transfer and method verification activities related to stability testing, ensuring successful implementation and validation of analytical methods across multiple laboratories. This includes protocol development, data review, and troubleshooting.
+ **Budget Management:** Develop and manage the budget for stability testing activities, ensuring cost-effective utilization of resources.
+ **Risk Management:** Conduct risk assessments related to stability and implement appropriate mitigation strategies.
+ **Team Leadership:** Lead, mentor, and develop a team of quality professionals. Provide clear direction, set performance expectations, and provide regular feedback. Foster a collaborative and high-performing team environment. Effectively delegate tasks and responsibilities to team members, ensuring appropriate workload distribution and skill development opportunities.
+ **Cross-Functional Collaboration:** Collaborate with project managers, Inventory Management, Sourcing, and other Quality Assurance team members to ensure seamless execution of stability studies and related activities.
+ **Communication:** Effectively communicate with internal and external stakeholders, providing updates on stability study progress, addressing technical issues, and ensuring alignment with project timelines and cGMP requirements. Ensure timely responses to inquiries and requests for information.
+ **GMP Compliance:** Ensure all stability activities are performed in compliance with cGMP regulations, company policies, and industry standards. Participate in internal and external audits, and implement corrective actions as necessary.
**_Qualifications_**
+ Bachelor's degree in a relevant scientific field preferred (e.g., Chemistry).
+ Minimum 8 years of experience in a GMP-regulated pharmaceutical quality oversight environment, with a focus on stability testing and data analysis preferred.
+ Prior experience in pharmaceutical repackaging, contract manufacturing, or generics is a plus.
+ In-depth knowledge of FDA regulations, ICH guidelines, USP monographs, and other relevant regulatory requirements related to stability testing and cGMP compliance.
+ Proficiency with Laboratory Information Management Systems (LIMS), electronic quality systems, statistical software and other relevant software applications used for data analysis and reporting, along with good documentation practices.
+ Demonstrated expertise in conducting OOS/OOT investigations, including root cause analysis and CAPA implementation. Experience managing investigations to meet established timelines.
+ Demonstrated expertise with inspections and audits from customers and regulators through active engagement and critical participation.
+ Experience with method transfer and method verification processes.
+ Experience in developing container closure strategy to ensure suitable packaging systems to achieve desirable outcomes is a plus.
+ Proven ability to lead and motivate a team, driving a culture of compliance, quality, and continuous improvement while balancing business goals and operational efficiency.
+ Drives core culture principles of accountability and ownership throughout the team and peers.
+ Experience in utilizing risk-based assessment methodologies that leverage mechanistic insights that may impact the quality and efficacy of drug product stability.
+ Strong problem-solving, analytical, and critical thinking skills, with the ability to identify and resolve complex issues related to stability testing and cGMP compliance in real time.
+ Excellent attention to detail, organizational skills, and the ability to manage multiple projects simultaneously.
+ Exceptional written and verbal communication skills, with the ability to effectively communicate complex scientific information to both technical and non-technical audiences, and to build strong relationships with internal and external business partners.
+ Effectively communicates and collaborates with senior leaders in the organization clearly and succinctly, taking into account corporate priorities and the goals of different departments and groups.
+ Ability to onboard and engage with external customers and vendors and forge strong working relationships to deliver excellent customer experience.
+ Thorough understanding of cGMP principles and practices, including data integrity requirements.
**_What is expected of you and others at this level_**
+ Manages department operations and supervises professional employees, front line supervisors and/or business support staff
+ Participates in the development of policies and procedures to achieve specific goals
+ Ensures employees operate within guidelines
+ Decisions have a short term impact on work processes, outcomes and customers
+ Interacts with subordinates, peers, customers, and suppliers at various management levels; may interact with senior management
+ Interactions normally involve resolution of issues related to operations and/or projects
+ Gains consensus from various parties involved
**Anticipated salary range:** $105,500 - $145,700
**Bonus eligible:** Yes
**Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with myFlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
**Application window anticipated to close:** 11/30/2025 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (
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0
Pharmacy Technician / Pharm Tech Apprenticeship
00617 Utuado, Puerto Rico
Walgreens
Posted 15 days ago
Job Viewed
Job Description
**Job Description:**
Our pharmacy technician positions have undergone an exciting transformation, moving from a transaction-based environment to a much more patient-centric one. As a Walgreens Pharmacy Technician or Pharmacy Technician Apprentice, you'll be front and center - interacting with our customers and developing strong patient relationships. Pharmacy is the core of our business, and our pharmacy technicians enjoy all the tools and support - including the latest technology - to grow their careers and reach their goals.
Walgreens is proud to invest & champion an "earn while you learn" Pharmacy Technician Training Program recognized by ASHP & Department of Labor. This apprenticeship program gives you an entry point to a career in health care by guiding you in taking steps towards becoming a Pharmacy Technician Certification Board (PTCB) Certified Pharmacy Technician and helping you maintain the high level of skill required in the pharmacy care industry. Arming you with a nationally recognized, portable credential that will help you advance your career.
Whether you are new to working in pharmacies or are an experienced Pharmacy Technician Apply Now! Walgreens will train you to use your skills and talents to serve and care for our patients and customers. The courses, learning activities, and resources provided to you in our pharmacy technician training program are designed to give you foundational and advanced knowledge, skills, and on-the-job experiences you need to prepare to become a certified pharmacy technician.
+ In accordance with state and federal regulations, assists the pharmacist, under direct supervision, in the practice of pharmacy. Assists the pharmacist in the performance of other Pharmacy Department duties in accordance with Company policies and procedures.
+ Responsible for using pharmacy systems to obtain patient and drug information and process prescriptions. If PTCB certified, assists with and coaches pharmacy technicians in the operation of pharmacy systems and cashiers in the operation of the pharmacy cash registers.
+ Models and delivers a distinctive and delightful customer experience.
**Customer Experience**
+ Engages customers and patients by greeting them and offering assistance with products and services. Resolves customer issues and answers questions to ensure a positive customer experience.
+ Models and shares customer service best practices with all team members to deliver a distinctive and delightful customer experience, including interpersonal habits (e.g., greeting, eye contact, courtesy, etc.) and Walgreens service traits (e.g., offering help proactively, identifying needs, servicing until satisfied, etc.).
+ Develops strong relationships with most valuable customers.
**Operations**
+ Under the supervision by the pharmacist, assist in the practice of pharmacy, in accordance with state, federal, and company policy. Reviews and complies with the Walgreen Co. Pharmacy Code of Conduct.
+ Performs duties as assigned by Pharmacy Manager, Staff Pharmacist and Store Manager including utilizing pharmacy systems to enter patient and drug information, ensuring information is entered correctly, filling prescriptions by retrieving, counting and pouring pharmaceutical drugs, verifying medicine is correct, and checking for possible interactions. Assists pharmacists in scheduling and maintaining work flow.
+ Reports, immediately, prescription errors to pharmacist on duty and adheres to Company policies and procedures in relation to pharmacy errors and the Quality Improvement Program.
+ Strictly adheres to the Walgreen Co. policy regarding Good Faith Dispensing during all applicable prescription dispensing activities.
+ Responsible and accountable for registering all related sales on assigned cash register, collects and handles cash as required. Takes customer to OTC aisle when possible to assist in locating products.
+ Handles telephone calls that do not require personal attention of the pharmacist, including those to physicians.
+ Processes (corrects and resubmits) manual claims for third party program prescription services in a timely and efficient manner, and performs other clerical duties, as assigned by the Pharmacy Manager.
+ Assists and supports Pharmacy Department on inventory management activities, such as, ordering, unpacking, checking and storing shipment of pharmaceuticals. Maintains knowledge of Company asset protection techniques, and files claims for warehouse overages (merchandise received, but not billed), shortages (merchandise billed, but not received), order errors or damaged goods involving Rx drugs.
+ May assist pharmacist in administering clinical services including the collection and proper labeling of blood/urine samples from patients and other clinical services as required; assists pharmacy staff in coordination of clinical services, Walgreens healthcare clinics and external providers.
+ Assists Pharmacy Manager and Staff Pharmacist in developing and maintaining good relationships with the local medical community, including physicians, nurses, and other health care providers, by medical provider detailing and outreach to health groups, retirement homes, nursing homes, and other forums for enhancing growth opportunities.
+ Assists with exterior and interior maintenance by ensuring the Pharmacy Department is stocked with adequate supplies, clean, neat and orderly in condition and appearance.
+ Complies with all company policies and procedures; maintains respectful relationships with coworkers.
+ Completes special assignments and other tasks as assigned.
**Training & Personal Development**
+ Earns and maintains PTCB certification through the designated PTCB training program and/or state required certification/registration. Otherwise, earns PTCB certification as condition of promotion to senior technician.
+ Attends training requested by Manager and acquires continuing education credits. Maintains knowledge and skill in healthcare and pharmacy, including latest news and developments.
**Job ID:** BR
**Title:** Pharmacy Technician / Pharm Tech Apprenticeship
**Company Indicator:** Walgreens
**Employment Type:** Part-time
**Job Function:** Retail
**Full Store Address:** 2 CARR 140,BARCELONETA,PR,00617
**Full District Office Address:** 2 CARR 140,BARCELONETA,PR, -S
**External Basic Qualifications:**
+ Must be fluent in reading, writing, and speaking English. (Except in Puerto Rico)
+ Requires willingness to work flexible schedule, including evening and weekend hours.
**Preferred Qualifications:**
+ Prefer six months of experience in a retail environment.
+ Prefer to have prior work experience with Walgreens.
+ Prefer good math skills so they can fill prescriptions accurately, including counting, measuring and weighing medications.
+ Prefer good computer skills.
+ Prefer the knowledge of store inventory control.
+ Prefer PTCB certification.
We will consider employment of qualified applicants with arrest and conviction records.
An Equal Opportunity Employer, including disability/veterans.
The actual compensation that you will be offered will depend on a variety of factors including geography, skills and abilities, education, experience and other relevant factors. This role will remain open until filled. To review benefits, please click here jobs.walgreens.com/benefits . If you are applying on a job board or unable to click on the link, please copy and paste this URL into your browser jobs.walgreens.com/benefits
**Shift:**
**Store:** 07564-BARCELONETA PR
**Pay Type:** Hourly
**Start Rate:** 17.5
**Max Rate:** 21
Our pharmacy technician positions have undergone an exciting transformation, moving from a transaction-based environment to a much more patient-centric one. As a Walgreens Pharmacy Technician or Pharmacy Technician Apprentice, you'll be front and center - interacting with our customers and developing strong patient relationships. Pharmacy is the core of our business, and our pharmacy technicians enjoy all the tools and support - including the latest technology - to grow their careers and reach their goals.
Walgreens is proud to invest & champion an "earn while you learn" Pharmacy Technician Training Program recognized by ASHP & Department of Labor. This apprenticeship program gives you an entry point to a career in health care by guiding you in taking steps towards becoming a Pharmacy Technician Certification Board (PTCB) Certified Pharmacy Technician and helping you maintain the high level of skill required in the pharmacy care industry. Arming you with a nationally recognized, portable credential that will help you advance your career.
Whether you are new to working in pharmacies or are an experienced Pharmacy Technician Apply Now! Walgreens will train you to use your skills and talents to serve and care for our patients and customers. The courses, learning activities, and resources provided to you in our pharmacy technician training program are designed to give you foundational and advanced knowledge, skills, and on-the-job experiences you need to prepare to become a certified pharmacy technician.
+ In accordance with state and federal regulations, assists the pharmacist, under direct supervision, in the practice of pharmacy. Assists the pharmacist in the performance of other Pharmacy Department duties in accordance with Company policies and procedures.
+ Responsible for using pharmacy systems to obtain patient and drug information and process prescriptions. If PTCB certified, assists with and coaches pharmacy technicians in the operation of pharmacy systems and cashiers in the operation of the pharmacy cash registers.
+ Models and delivers a distinctive and delightful customer experience.
**Customer Experience**
+ Engages customers and patients by greeting them and offering assistance with products and services. Resolves customer issues and answers questions to ensure a positive customer experience.
+ Models and shares customer service best practices with all team members to deliver a distinctive and delightful customer experience, including interpersonal habits (e.g., greeting, eye contact, courtesy, etc.) and Walgreens service traits (e.g., offering help proactively, identifying needs, servicing until satisfied, etc.).
+ Develops strong relationships with most valuable customers.
**Operations**
+ Under the supervision by the pharmacist, assist in the practice of pharmacy, in accordance with state, federal, and company policy. Reviews and complies with the Walgreen Co. Pharmacy Code of Conduct.
+ Performs duties as assigned by Pharmacy Manager, Staff Pharmacist and Store Manager including utilizing pharmacy systems to enter patient and drug information, ensuring information is entered correctly, filling prescriptions by retrieving, counting and pouring pharmaceutical drugs, verifying medicine is correct, and checking for possible interactions. Assists pharmacists in scheduling and maintaining work flow.
+ Reports, immediately, prescription errors to pharmacist on duty and adheres to Company policies and procedures in relation to pharmacy errors and the Quality Improvement Program.
+ Strictly adheres to the Walgreen Co. policy regarding Good Faith Dispensing during all applicable prescription dispensing activities.
+ Responsible and accountable for registering all related sales on assigned cash register, collects and handles cash as required. Takes customer to OTC aisle when possible to assist in locating products.
+ Handles telephone calls that do not require personal attention of the pharmacist, including those to physicians.
+ Processes (corrects and resubmits) manual claims for third party program prescription services in a timely and efficient manner, and performs other clerical duties, as assigned by the Pharmacy Manager.
+ Assists and supports Pharmacy Department on inventory management activities, such as, ordering, unpacking, checking and storing shipment of pharmaceuticals. Maintains knowledge of Company asset protection techniques, and files claims for warehouse overages (merchandise received, but not billed), shortages (merchandise billed, but not received), order errors or damaged goods involving Rx drugs.
+ May assist pharmacist in administering clinical services including the collection and proper labeling of blood/urine samples from patients and other clinical services as required; assists pharmacy staff in coordination of clinical services, Walgreens healthcare clinics and external providers.
+ Assists Pharmacy Manager and Staff Pharmacist in developing and maintaining good relationships with the local medical community, including physicians, nurses, and other health care providers, by medical provider detailing and outreach to health groups, retirement homes, nursing homes, and other forums for enhancing growth opportunities.
+ Assists with exterior and interior maintenance by ensuring the Pharmacy Department is stocked with adequate supplies, clean, neat and orderly in condition and appearance.
+ Complies with all company policies and procedures; maintains respectful relationships with coworkers.
+ Completes special assignments and other tasks as assigned.
**Training & Personal Development**
+ Earns and maintains PTCB certification through the designated PTCB training program and/or state required certification/registration. Otherwise, earns PTCB certification as condition of promotion to senior technician.
+ Attends training requested by Manager and acquires continuing education credits. Maintains knowledge and skill in healthcare and pharmacy, including latest news and developments.
**Job ID:** BR
**Title:** Pharmacy Technician / Pharm Tech Apprenticeship
**Company Indicator:** Walgreens
**Employment Type:** Part-time
**Job Function:** Retail
**Full Store Address:** 2 CARR 140,BARCELONETA,PR,00617
**Full District Office Address:** 2 CARR 140,BARCELONETA,PR, -S
**External Basic Qualifications:**
+ Must be fluent in reading, writing, and speaking English. (Except in Puerto Rico)
+ Requires willingness to work flexible schedule, including evening and weekend hours.
**Preferred Qualifications:**
+ Prefer six months of experience in a retail environment.
+ Prefer to have prior work experience with Walgreens.
+ Prefer good math skills so they can fill prescriptions accurately, including counting, measuring and weighing medications.
+ Prefer good computer skills.
+ Prefer the knowledge of store inventory control.
+ Prefer PTCB certification.
We will consider employment of qualified applicants with arrest and conviction records.
An Equal Opportunity Employer, including disability/veterans.
The actual compensation that you will be offered will depend on a variety of factors including geography, skills and abilities, education, experience and other relevant factors. This role will remain open until filled. To review benefits, please click here jobs.walgreens.com/benefits . If you are applying on a job board or unable to click on the link, please copy and paste this URL into your browser jobs.walgreens.com/benefits
**Shift:**
**Store:** 07564-BARCELONETA PR
**Pay Type:** Hourly
**Start Rate:** 17.5
**Max Rate:** 21
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1
Assistant General Counsel - Specialty Pharmaceutical Distribution
00918 San Juan, Puerto Rico
Cardinal Health
Posted 15 days ago
Job Viewed
Job Description
**_What the Legal Department contributes to Cardinal Health_**
Legal provides the company with strategic, proactive, practical and cost-effective legal advice and services in order to protect the organization's assets, operations and image. This function provides legal counsel related to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company legal matters, manages outside counsel and manages legal operations.
Legal Management provides strategic oversight, leadership and direction within the Legal function.
**_Job Summary_**
The Assistant General Counsel - Specialty Pharmaceutical Distribution will be responsible for providing exceptional legal advice and guidance to the Specialty Pharmaceutical Distribution segment business clients.
**_Responsibilities_**
+ Demonstrate strong business acumen and ability to draft and negotiate contracts
+ Handle fast paced and high-volume workload
+ Identify legal and compliance issues and business risks and escalate appropriately
+ Effectively communicate with all levels of the Cardinal Health organization
+ Identify and collaborate with subject matter experts from other departments, especially the Legal, Regulatory Counsel and Compliance teams
+ Demonstrate knowledge of general commercial and healthcare law; specifically, regulations related to pharmaceutical distribution and services and group purchasing organizations, specifically AKS/Fraud & Abuse
+ Identify opportunities for process improvements and efficiencies
+ Work under the general supervision of senior attorneys and exercise sound judgment as to matters that require attention of Legal and Compliance Departments' senior leadership
+ Promote and ensure compliance with the Cardinal Health's Business Code of Conduct, as well as other company policies and procedures
+ Provide sound, practical judgment in the interpretation and application of relevant laws including, Antitrust; healthcare laws and regulations, (e.g., Stark, Corporate Practice of Medicine, Anti-Kickback, False Claims Act, and HIPAA); and Marketing and Advertising
+ Proactively identify and assesses business and legal risks
+ Demonstrate excellent communication skills and ability to provide business clients with clear and precise guidance on business, compliance, and legal risks
+ Develop and conduct legal training for business clients
+ Seek input and expertise from other in-house lawyers and outside counsel and provide guidance to the business based on discussions with subject-matter experts
+ Understand complex legal, compliance and business situations and discerns relevant versus non-relevant facts and information
+ Collaborate with others and build knowledge of business and key stakeholders
+ Proactively develop and maintain legal knowledge in specialized area(s), remaining up to date on current regulations, cases, trends and best practices
+ Identify opportunities to improve efficiency while providing flawless service levels
+ Communicate in a professional and persuasive manner and has appropriate support and substantiation for legal advice and recommendations
**_Qualifications_**
+ 10+ years of experience preferred
+ Law firm or in-house healthcare experience preferred, including commercial transactions and fraud and abuse compliance expertise
+ Experience working with Group Purchasing Organizations, Integrated Delivery Networks and pharmaceutical manufacturers preferred
+ J.D. required; record of high academic achievement in the undergraduate level and in law school preferred
+ License to practice law in Ohio or active bar license in another state required
+ Excellent oral and written communication skills; acute attention to detail
+ Outstanding interpersonal skills, including diplomacy and flexibility, and the ability to interface effectively and engender trust and confidence with personnel at many different levels throughout the company
+ Enthusiasm and "self-starter" qualities, enabling management of responsibilities with an appropriate sense of urgency; the ability to function effectively and efficiently in a fast-paced and dynamic environment
+ Business acumen, including a well-developed understanding of business and commerce and the ability to diagnose corporate legal problems and present positive, creative solutions and alternatives
+ Have excellent writing and contract drafting and negotiating skills
+ Ability to develop and implement policies, projects, processes, systems and controls across a complex company
+ Ability to work independently, cross-functionally and collaboratively
**_What is expected of you and others at this level_**
+ Develops and implements policies and procedures to achieve organizational goals
+ Assists in the development of functional strategy
+ Decisions have an extended impact on work processes, outcomes, and customers
+ Interacts with internal and/or external leaders, including senior management
+ Persuades others into agreement in sensitive situations while maintaining positive relationships
**Anticipated salary range:** $132,700 - $204,000
**Bonus eligible:** Yes
**Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with myFlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
**Application window anticipated to close:** 8/15/25 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (
Legal provides the company with strategic, proactive, practical and cost-effective legal advice and services in order to protect the organization's assets, operations and image. This function provides legal counsel related to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company legal matters, manages outside counsel and manages legal operations.
Legal Management provides strategic oversight, leadership and direction within the Legal function.
**_Job Summary_**
The Assistant General Counsel - Specialty Pharmaceutical Distribution will be responsible for providing exceptional legal advice and guidance to the Specialty Pharmaceutical Distribution segment business clients.
**_Responsibilities_**
+ Demonstrate strong business acumen and ability to draft and negotiate contracts
+ Handle fast paced and high-volume workload
+ Identify legal and compliance issues and business risks and escalate appropriately
+ Effectively communicate with all levels of the Cardinal Health organization
+ Identify and collaborate with subject matter experts from other departments, especially the Legal, Regulatory Counsel and Compliance teams
+ Demonstrate knowledge of general commercial and healthcare law; specifically, regulations related to pharmaceutical distribution and services and group purchasing organizations, specifically AKS/Fraud & Abuse
+ Identify opportunities for process improvements and efficiencies
+ Work under the general supervision of senior attorneys and exercise sound judgment as to matters that require attention of Legal and Compliance Departments' senior leadership
+ Promote and ensure compliance with the Cardinal Health's Business Code of Conduct, as well as other company policies and procedures
+ Provide sound, practical judgment in the interpretation and application of relevant laws including, Antitrust; healthcare laws and regulations, (e.g., Stark, Corporate Practice of Medicine, Anti-Kickback, False Claims Act, and HIPAA); and Marketing and Advertising
+ Proactively identify and assesses business and legal risks
+ Demonstrate excellent communication skills and ability to provide business clients with clear and precise guidance on business, compliance, and legal risks
+ Develop and conduct legal training for business clients
+ Seek input and expertise from other in-house lawyers and outside counsel and provide guidance to the business based on discussions with subject-matter experts
+ Understand complex legal, compliance and business situations and discerns relevant versus non-relevant facts and information
+ Collaborate with others and build knowledge of business and key stakeholders
+ Proactively develop and maintain legal knowledge in specialized area(s), remaining up to date on current regulations, cases, trends and best practices
+ Identify opportunities to improve efficiency while providing flawless service levels
+ Communicate in a professional and persuasive manner and has appropriate support and substantiation for legal advice and recommendations
**_Qualifications_**
+ 10+ years of experience preferred
+ Law firm or in-house healthcare experience preferred, including commercial transactions and fraud and abuse compliance expertise
+ Experience working with Group Purchasing Organizations, Integrated Delivery Networks and pharmaceutical manufacturers preferred
+ J.D. required; record of high academic achievement in the undergraduate level and in law school preferred
+ License to practice law in Ohio or active bar license in another state required
+ Excellent oral and written communication skills; acute attention to detail
+ Outstanding interpersonal skills, including diplomacy and flexibility, and the ability to interface effectively and engender trust and confidence with personnel at many different levels throughout the company
+ Enthusiasm and "self-starter" qualities, enabling management of responsibilities with an appropriate sense of urgency; the ability to function effectively and efficiently in a fast-paced and dynamic environment
+ Business acumen, including a well-developed understanding of business and commerce and the ability to diagnose corporate legal problems and present positive, creative solutions and alternatives
+ Have excellent writing and contract drafting and negotiating skills
+ Ability to develop and implement policies, projects, processes, systems and controls across a complex company
+ Ability to work independently, cross-functionally and collaboratively
**_What is expected of you and others at this level_**
+ Develops and implements policies and procedures to achieve organizational goals
+ Assists in the development of functional strategy
+ Decisions have an extended impact on work processes, outcomes, and customers
+ Interacts with internal and/or external leaders, including senior management
+ Persuades others into agreement in sensitive situations while maintaining positive relationships
**Anticipated salary range:** $132,700 - $204,000
**Bonus eligible:** Yes
**Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with myFlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
**Application window anticipated to close:** 8/15/25 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (
View Now
2
Senior Director, MSAT Biologics
00918 San Juan, Puerto Rico
Otsuka America Pharmaceutical Inc.
Posted 15 days ago
Job Viewed
Job Description
**Position Overview:**
The Senior Director, MSAT Biologics provides strategic and technical leadership for all late-stage and commercial manufacturing processes for the company's biologics portfolio executed at CDMOs. This role is responsible for building and leading the MSAT team, ensuring robust and compliant manufacturing processes through effective technology transfer, validation, process monitoring, and lifecycle management. This individual will serve as the primary technical steward for manufacturing processes, ensuring strong collaboration between internal functions and external partners.
**Key Responsibilities:**
+ Develop and implement the overall MSAT strategy supporting the company's portfolio, focusing on technical oversight of CDMO manufacturing operations.
+ Build, lead, mentor, and manage the MSAT team, fostering a culture of scientific excellence, collaboration, and accountability.
+ Provide senior technical leadership and oversight for technology transfer activities to new or existing CDMOs.
+ Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards.
+ Establish and oversee robust Continued Process Verification (CPV) programs for commercial products.
+ Serve as the primary technical point of contact for CDMOs regarding process performance, troubleshooting, and improvements.
+ Lead complex manufacturing investigations and deviations, ensuring thorough root cause analysis and effective CAPA implementation at CDMOs.
+ Drive strategies for process optimization, yield improvement, and manufacturing cost reduction where appropriate.
+ Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Operations to align strategies and optimize product lifecycle management
+ Lead root cause investigations for manufacturing deviations and implement corrective and preventive actions
+ Stay abreast of emerging trends and technologies in biologics manufacturing, recommending and implementing innovations where appropriate
+ Ensure compliance with cGMP regulations and other relevant quality standards
+ Represent the MSAT function in interactions with regulatory agencies and during audits
+ Manage budgets and resources effectively to meet departmental and organizational goals
**Qualifications:**
+ Ph.D. in Biochemistry, Biotechnology, Chemical Engineering, or a related field
+ Minimum 15 years of experience in biologics manufacturing, with at least 5 years in a senior leadership role
+ Deep understanding of upstream and downstream bioprocessing, including cell culture, purification, and formulation
+ Proven track record in process development, scale-up, and technology transfer of biologics products
+ Strong knowledge of cGMP regulations and ICH guidelines relevant to biologics manufacturing
+ Experience with PAT (Process Analytical Technology) and QbD (Quality by Design) principles
+ Excellent leadership and team management skills, with the ability to motivate and develop staff
+ Strong analytical and problem-solving skills, with a data-driven approach to decision-making
+ Outstanding communication skills, both written and verbal, with the ability to influence at all levels of the organization
+ Experience in managing complex projects and driving continuous improvement initiatives
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
**Company benefits** : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request ( ) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: . If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
The Senior Director, MSAT Biologics provides strategic and technical leadership for all late-stage and commercial manufacturing processes for the company's biologics portfolio executed at CDMOs. This role is responsible for building and leading the MSAT team, ensuring robust and compliant manufacturing processes through effective technology transfer, validation, process monitoring, and lifecycle management. This individual will serve as the primary technical steward for manufacturing processes, ensuring strong collaboration between internal functions and external partners.
**Key Responsibilities:**
+ Develop and implement the overall MSAT strategy supporting the company's portfolio, focusing on technical oversight of CDMO manufacturing operations.
+ Build, lead, mentor, and manage the MSAT team, fostering a culture of scientific excellence, collaboration, and accountability.
+ Provide senior technical leadership and oversight for technology transfer activities to new or existing CDMOs.
+ Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards.
+ Establish and oversee robust Continued Process Verification (CPV) programs for commercial products.
+ Serve as the primary technical point of contact for CDMOs regarding process performance, troubleshooting, and improvements.
+ Lead complex manufacturing investigations and deviations, ensuring thorough root cause analysis and effective CAPA implementation at CDMOs.
+ Drive strategies for process optimization, yield improvement, and manufacturing cost reduction where appropriate.
+ Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Operations to align strategies and optimize product lifecycle management
+ Lead root cause investigations for manufacturing deviations and implement corrective and preventive actions
+ Stay abreast of emerging trends and technologies in biologics manufacturing, recommending and implementing innovations where appropriate
+ Ensure compliance with cGMP regulations and other relevant quality standards
+ Represent the MSAT function in interactions with regulatory agencies and during audits
+ Manage budgets and resources effectively to meet departmental and organizational goals
**Qualifications:**
+ Ph.D. in Biochemistry, Biotechnology, Chemical Engineering, or a related field
+ Minimum 15 years of experience in biologics manufacturing, with at least 5 years in a senior leadership role
+ Deep understanding of upstream and downstream bioprocessing, including cell culture, purification, and formulation
+ Proven track record in process development, scale-up, and technology transfer of biologics products
+ Strong knowledge of cGMP regulations and ICH guidelines relevant to biologics manufacturing
+ Experience with PAT (Process Analytical Technology) and QbD (Quality by Design) principles
+ Excellent leadership and team management skills, with the ability to motivate and develop staff
+ Strong analytical and problem-solving skills, with a data-driven approach to decision-making
+ Outstanding communication skills, both written and verbal, with the ability to influence at all levels of the organization
+ Experience in managing complex projects and driving continuous improvement initiatives
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
**Company benefits** : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request ( ) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: . If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
View Now
3
Principal Product Manager - Clinical AI Agents
00918 San Juan, Puerto Rico
Oracle
Posted 15 days ago
Job Viewed
Job Description
**Job Description**
The Oracle Clinical AI Agent team's mission is to deliver an AI platform that serves as the foundation for Oracle's health applications. By embedding generative and conversational AI into these applications, we empower clinicians to simplify their workflows, reduce manual tasks, and focus more on patient care. Our diverse team of innovators is building the future of conversational clinical interfaces-improving the lives of patients and providers worldwide. We work with the agility of a start-up and the impact of an industry leader. Join us and shape the future of healthcare.
We are seeking a highly motivated Principal Product Manager to drive the end-to-end development of Clinical AI Agents-from concept to release. In this role, you will work closely with data science, engineering, and UX to explore new opportunity spaces, define gold-standard training data requirements, guide the model development lifecycle, and ensure the delivery of safe, effective, and clinically useful AI agents.
**Your Qualifications:**
+ 7+ years of professional experience in product management
+ 2+ years of experience delivering AI/ML products, ideally in multiple industries
+ Familiarity with large datasets, analytics, and user engagement metrics
+ Experience in clinical workflows and regulated healthcare environments is preferred
+ Knowledge of data privacy and compliance requirements within healthcare settings is advantageous
**Preferred Qualifications:**
+ Experience with LLMs, Generative AI and agent-based solutions
+ Demonstrated success launching 0-to-1 products and achieving market traction
+ Bachelor's degree in computer science, Engineering, or equivalent experience
**Your Responsibilities:**
+ Define Product Strategy & Roadmap: Craft and maintain product roadmaps focused on delivering engaging, user-centric features that encourage clinicians and healthcare staff to adopt AI-powered capabilities in their daily workflows.
+ Apply AI & Emerging Technologies: Stay current with advances in NLP, large language models, and generative AI. Adapt these technologies to streamline clinical workflows, differentiate from competitors, and deliver measurable improvements in efficiency and patient outcomes.
+ Define and Explore Opportunity Areas: Partner with clinicians, researchers, and internal stakeholders to identify high-value clinical workflows that can be transformed using AI agents.
+ Lead Concept Development: Translate abstract ideas and unmet needs into structured product concepts, defining the problem space, success criteria, and technical feasibility.
+ Collaborate Across Functions: Work hand-in-hand with data science, engineering, and UX teams to shape agent behavior, training strategies, and user experience.
+ Gold Data Strategy & Acquisition: Drive the creation and curation of high-quality, representative datasets required for training and validating agent models, including annotation guidelines and domain coverage.
+ Model Development Oversight: Coordinate the training, tuning, and evaluation of models-ensuring alignment with clinical intent, performance benchmarks, and compliance standards.
+ Validation & Safety Testing: Develop validation protocols to test agent performance, usability, and clinical safety in real-world-like environments prior to release.
+ Product Readiness & Delivery: Collaborate on release planning, documentation, and internal enablement to support the smooth launch of new agent capabilities.
+ Compliance & Risk Awareness: Ensure that Clinical AI Agents meet healthcare industry standards for data privacy, transparency, and reliability.
+ Customer Engagement & Feedback Loops: Identify lead customers, cultivate design partnerships, and incorporate direct user feedback to validate assumptions, guide product evolution, and ensure clinical needs remain at the forefront of innovation.
Career Level - IC4
Join us to shape the future of healthcare, transforming how clinicians deliver care through AI-driven solutions that enhance efficiency, reduce burnout, and improve patient outcomes.
**Responsibilities**
As a member of the product development division, you will analyze and integrate external customer specifications. Suggest and justify product directions and specifications. Specify, design and implement moderate changes to existing software architecture. Build new products and development tools. Build and execute unit tests and unit test plans. Review integration and regression test plans created by QA. Communicate with QA and porting engineering to discuss major changes to functionality.
Disclaimer:
**Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.**
**Range and benefit information provided in this posting are specific to the stated locations only**
US: Hiring Range in USD from: $92,900 to $199,500 per annum. May be eligible for bonus and equity.
Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business.
Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.
Oracle US offers a comprehensive benefits package which includes the following:
1. Medical, dental, and vision insurance, including expert medical opinion
2. Short term disability and long term disability
3. Life insurance and AD&D
4. Supplemental life insurance (Employee/Spouse/Child)
5. Health care and dependent care Flexible Spending Accounts
6. Pre-tax commuter and parking benefits
7. 401(k) Savings and Investment Plan with company match
8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
9. 11 paid holidays
10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
11. Paid parental leave
12. Adoption assistance
13. Employee Stock Purchase Plan
14. Financial planning and group legal
15. Voluntary benefits including auto, homeowner and pet insurance
The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.
Career Level - IC4
**About Us**
As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.
We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing or by calling in the United States.
Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
The Oracle Clinical AI Agent team's mission is to deliver an AI platform that serves as the foundation for Oracle's health applications. By embedding generative and conversational AI into these applications, we empower clinicians to simplify their workflows, reduce manual tasks, and focus more on patient care. Our diverse team of innovators is building the future of conversational clinical interfaces-improving the lives of patients and providers worldwide. We work with the agility of a start-up and the impact of an industry leader. Join us and shape the future of healthcare.
We are seeking a highly motivated Principal Product Manager to drive the end-to-end development of Clinical AI Agents-from concept to release. In this role, you will work closely with data science, engineering, and UX to explore new opportunity spaces, define gold-standard training data requirements, guide the model development lifecycle, and ensure the delivery of safe, effective, and clinically useful AI agents.
**Your Qualifications:**
+ 7+ years of professional experience in product management
+ 2+ years of experience delivering AI/ML products, ideally in multiple industries
+ Familiarity with large datasets, analytics, and user engagement metrics
+ Experience in clinical workflows and regulated healthcare environments is preferred
+ Knowledge of data privacy and compliance requirements within healthcare settings is advantageous
**Preferred Qualifications:**
+ Experience with LLMs, Generative AI and agent-based solutions
+ Demonstrated success launching 0-to-1 products and achieving market traction
+ Bachelor's degree in computer science, Engineering, or equivalent experience
**Your Responsibilities:**
+ Define Product Strategy & Roadmap: Craft and maintain product roadmaps focused on delivering engaging, user-centric features that encourage clinicians and healthcare staff to adopt AI-powered capabilities in their daily workflows.
+ Apply AI & Emerging Technologies: Stay current with advances in NLP, large language models, and generative AI. Adapt these technologies to streamline clinical workflows, differentiate from competitors, and deliver measurable improvements in efficiency and patient outcomes.
+ Define and Explore Opportunity Areas: Partner with clinicians, researchers, and internal stakeholders to identify high-value clinical workflows that can be transformed using AI agents.
+ Lead Concept Development: Translate abstract ideas and unmet needs into structured product concepts, defining the problem space, success criteria, and technical feasibility.
+ Collaborate Across Functions: Work hand-in-hand with data science, engineering, and UX teams to shape agent behavior, training strategies, and user experience.
+ Gold Data Strategy & Acquisition: Drive the creation and curation of high-quality, representative datasets required for training and validating agent models, including annotation guidelines and domain coverage.
+ Model Development Oversight: Coordinate the training, tuning, and evaluation of models-ensuring alignment with clinical intent, performance benchmarks, and compliance standards.
+ Validation & Safety Testing: Develop validation protocols to test agent performance, usability, and clinical safety in real-world-like environments prior to release.
+ Product Readiness & Delivery: Collaborate on release planning, documentation, and internal enablement to support the smooth launch of new agent capabilities.
+ Compliance & Risk Awareness: Ensure that Clinical AI Agents meet healthcare industry standards for data privacy, transparency, and reliability.
+ Customer Engagement & Feedback Loops: Identify lead customers, cultivate design partnerships, and incorporate direct user feedback to validate assumptions, guide product evolution, and ensure clinical needs remain at the forefront of innovation.
Career Level - IC4
Join us to shape the future of healthcare, transforming how clinicians deliver care through AI-driven solutions that enhance efficiency, reduce burnout, and improve patient outcomes.
**Responsibilities**
As a member of the product development division, you will analyze and integrate external customer specifications. Suggest and justify product directions and specifications. Specify, design and implement moderate changes to existing software architecture. Build new products and development tools. Build and execute unit tests and unit test plans. Review integration and regression test plans created by QA. Communicate with QA and porting engineering to discuss major changes to functionality.
Disclaimer:
**Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.**
**Range and benefit information provided in this posting are specific to the stated locations only**
US: Hiring Range in USD from: $92,900 to $199,500 per annum. May be eligible for bonus and equity.
Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business.
Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.
Oracle US offers a comprehensive benefits package which includes the following:
1. Medical, dental, and vision insurance, including expert medical opinion
2. Short term disability and long term disability
3. Life insurance and AD&D
4. Supplemental life insurance (Employee/Spouse/Child)
5. Health care and dependent care Flexible Spending Accounts
6. Pre-tax commuter and parking benefits
7. 401(k) Savings and Investment Plan with company match
8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
9. 11 paid holidays
10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
11. Paid parental leave
12. Adoption assistance
13. Employee Stock Purchase Plan
14. Financial planning and group legal
15. Voluntary benefits including auto, homeowner and pet insurance
The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.
Career Level - IC4
**About Us**
As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.
We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing or by calling in the United States.
Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
View Now
4
Life Sciences Senior Project Manager - Talent Community
00694 Vega Baja, Puerto Rico
CBRE
Posted 15 days ago
Job Viewed
Job Description
Life Sciences Senior Project Manager - Talent Community
Job ID
Posted
22-May-2025
Service line
PJM Segment
Role type
Full-time
Areas of Interest
Construction, Project Management
Location(s)
Bayamon - Puerto Rico - United States of America, Caguas - Puerto Rico - United States of America, Carolina - Puerto Rico - United States of America, Coamo - Puerto Rico - United States of America, Fajardo - Puerto Rico - United States of America, Guayama - Puerto Rico - United States of America, Guaynabo - Puerto Rico - United States of America, Luquillo - Puerto Rico - United States of America, Rio Grande - Puerto Rico - United States of America, San Juan - Puerto Rico - United States of America, Vega Baja - Puerto Rico - United States of America
CBRE is using this platform to provide general information to individuals who want to learn more about a career at CBRE. If an opportunity opens that matches your qualifications, we will reach out to you at that time. We are growing a world-class organization with a world-class team and appreciate your interest in CBRE. We welcome you to explore our Careers ( page and apply directly to any positions that interest you. We will not consider the submission of resumes on this platform as an expression of interest in any posted position at CBRE.
**CBRE / Turner and Townsend currently have multiple opportunities within Project Management for our Life Sciences clients in Puerto Rico. We are currently seeking bilingual (Spanish/English) Project Managers with cGMP experience.**
**About The Role**
As a Life Sciences Senior Project Manager you will manage and lead design and construction teams responsible for multi-disciplined real estate / capital project solutions for clients in the Commercial /Life Sciences / Biotech / Pharmaceuticals market sector, with direct accountability for project delivery.
Preferred experience in regulated areas such as imaging, animal studies, laboratories, environmentally-controlled areas, and production areas thus the candidate should be familiar with pharmaceutical current good manufacturing practices (cGMP) including commissioning processes.
The work will include civil, infrastructure, structural, and interior projects in administrative, laboratories, production, and warehouse areas, regulated and non-regulated environments, and plant utility areas.
What you'll do
+ Experience in all facets of project management (resources, budget, schedule, procurement, quality & risk assessment) for projects including planning, design, construction, occupancy, and closeout.
+ Experience interpreting and applying knowledge on sophisticated documents affecting real estate / construction projects, including but not limited to: agreements/contracts, leases, work letters, project charters, architectural and engineering design, construction documentation, and construction administration / management practices.
+ Interfaces directly with clients to define project requirements, prepare scope of work, project delivery resource requirements, oversee cost estimate & budget preparation, review cash flow, work plan schedule & milestones, quality control, and risk identification.
+ Experience with Collaborative, Integrated, and Lean Project Delivery methods is a plus.
+ Identify project delivery resources from pre-qualified lists, or through individual project qualification process; conducts standard to complex request for proposals; completes bid analysis; leads evaluation interviews, recommends resources to clients. Lead project delivery resources/team (typically larger more experienced team) providing project mentorship and direction to achieve project goals
+ Implement communication plan for meetings and written reports/meeting minutes to keep client and project resources advised and aligned. Facilitate project meetings. Implement project documentation governance aligned with company and client requirements. Ensure project data integrity and documentation is accurate, timely and coordinated.
+ Track progress of each project against goals, objectives, approved budgets, approved timelines. Reports status and variances. Creates action plans to meet objectives, budget and schedule.
+ Implement change management routines to assess change requests, make recommendations, secure client approvals, and issue change orders. Assesses change requests to determine impacts to scope, budget, schedule, quality and risk.
+ Demonstrates ability to identify complex project risks, lead constructability reviews, develop risk mitigation and contingency plans, and implement action plans to reduce or eliminate project risks.
+ Manage multi-site portfolio for client.
+ Has a growth mindset for the client and the team built to execute the project/program.
+ Demonstrate a knowledge of projects & project management within the context of business results (business case, larger economic implications, business risk, etc.).
+ Other duties as assigned.
What you'll need
Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future.
+ Bachelor's degree (BA/BS/BEng/BArch) from College or University in a technical area of study. Prior experience in the pharma, life sciences, or health care industry preferred but not vital as a condition for consideration.
+ 8+ years of progressive experience in design, engineering, or construction management, with 5+ years' experience focused on life science, healthcare or lab facilities which may include biology, cell/gene therapy, chemistry, pharmaceutical, cGMP process manufacturing, agricultural / food science, vivarium, bio-containment, academic research, public health and/or clinical labs.
+ Acts as Subject Matter Expert on design and construction strategies for A/S/M/E/P/P building systems on life science projects and with ability to lead project teams through the decision-making process which result in high value, safe, adaptable, sustainable, flexible, and robust science facilities.
+ Significant experience leading the programming, design, and construction phases on life science projects including laboratory research facilities. Experience with cGMP facilities is a plus.
+ Provide Subject Matter leadership on design and construction strategies for architectural and engineering systems on life science projects with an ability to lead project teams through the decision-making process to deliver high value, safe, responsive, sustainable, flexible, and robust facilities.
+ Knowledge of building codes, standards and building structures for life science facilities.
+ Participate in the growth of CBRE & T&T's Life Sciences Practice Area through industry, marketing, and business development activities. Current participation with community, industry and professional life science organizations is a plus. Relationships with decision-makers at end-user science organizations is a plus.
+ Ability to comprehend, analyze, and interpret complex business documents and respond effectively to critical issues. Ability to make effective and persuasive presentations on various topics to employees, clients, top management and/or public groups. Ability to motivate and negotiate effectively with key employees, top management, and client groups to take desired action.
+ Intermediate skills with Microsoft Office Suite and client control platforms. Ability to read and understand architectural drawings. Knowledge in MS Project, leases, contracts, and construction practices.
+ Ability to solve advanced problems and deal with a variety of options in complex situations. Proven experience in developing strategic solutions for a growing matrix-based multi-industry sales environment. Ability to draw upon the analysis of others and make recommendations that have a direct impact on the company.
+ Ability to forecast and prepare budgets, conduct analysis and prepare or review financial report.
+ Bilingual English - Spanish preferred.
+ License or Certificate in Architecture, Engineering, or Construction Management, PMP (US and/or Canada) and LEED AP preferred.
Disclaimer:
Please be advised that effective January 1, 2025, CBRE Project Management and Turner &Townsend was consolidated into a single global business entity. As a candidate applying for a position, you should be aware that while your initial employment may be with Turner & Townsend PJM US LLC, you will subsequently transfer directly to Turner & Townsend at a date to be determined.
**Equal Employment Opportunity:** CBRE has a long-standing commitment to providing equal employment opportunity to all qualified applicants regardless of race, color, religion, national origin, sex, sexual orientation, gender identity, pregnancy, age, citizenship, marital status, disability, veteran status, political belief, or any other basis protected by applicable law.
**Candidate Accommodations:** CBRE values the differences of all current and prospective employees and recognizes how every employee contributes to our company's success. CBRE provides reasonable accommodations in job application procedures for individuals with disabilities. If you require assistance due to a disability in the application or recruitment process, please submit a request via email at or via telephone at (U.S.) and (Canada).
CBRE, Inc. is an Equal Opportunity and Affirmative Action Employer (Women/Minorities/Persons with Disabilities/US Veterans)
Job ID
Posted
22-May-2025
Service line
PJM Segment
Role type
Full-time
Areas of Interest
Construction, Project Management
Location(s)
Bayamon - Puerto Rico - United States of America, Caguas - Puerto Rico - United States of America, Carolina - Puerto Rico - United States of America, Coamo - Puerto Rico - United States of America, Fajardo - Puerto Rico - United States of America, Guayama - Puerto Rico - United States of America, Guaynabo - Puerto Rico - United States of America, Luquillo - Puerto Rico - United States of America, Rio Grande - Puerto Rico - United States of America, San Juan - Puerto Rico - United States of America, Vega Baja - Puerto Rico - United States of America
CBRE is using this platform to provide general information to individuals who want to learn more about a career at CBRE. If an opportunity opens that matches your qualifications, we will reach out to you at that time. We are growing a world-class organization with a world-class team and appreciate your interest in CBRE. We welcome you to explore our Careers ( page and apply directly to any positions that interest you. We will not consider the submission of resumes on this platform as an expression of interest in any posted position at CBRE.
**CBRE / Turner and Townsend currently have multiple opportunities within Project Management for our Life Sciences clients in Puerto Rico. We are currently seeking bilingual (Spanish/English) Project Managers with cGMP experience.**
**About The Role**
As a Life Sciences Senior Project Manager you will manage and lead design and construction teams responsible for multi-disciplined real estate / capital project solutions for clients in the Commercial /Life Sciences / Biotech / Pharmaceuticals market sector, with direct accountability for project delivery.
Preferred experience in regulated areas such as imaging, animal studies, laboratories, environmentally-controlled areas, and production areas thus the candidate should be familiar with pharmaceutical current good manufacturing practices (cGMP) including commissioning processes.
The work will include civil, infrastructure, structural, and interior projects in administrative, laboratories, production, and warehouse areas, regulated and non-regulated environments, and plant utility areas.
What you'll do
+ Experience in all facets of project management (resources, budget, schedule, procurement, quality & risk assessment) for projects including planning, design, construction, occupancy, and closeout.
+ Experience interpreting and applying knowledge on sophisticated documents affecting real estate / construction projects, including but not limited to: agreements/contracts, leases, work letters, project charters, architectural and engineering design, construction documentation, and construction administration / management practices.
+ Interfaces directly with clients to define project requirements, prepare scope of work, project delivery resource requirements, oversee cost estimate & budget preparation, review cash flow, work plan schedule & milestones, quality control, and risk identification.
+ Experience with Collaborative, Integrated, and Lean Project Delivery methods is a plus.
+ Identify project delivery resources from pre-qualified lists, or through individual project qualification process; conducts standard to complex request for proposals; completes bid analysis; leads evaluation interviews, recommends resources to clients. Lead project delivery resources/team (typically larger more experienced team) providing project mentorship and direction to achieve project goals
+ Implement communication plan for meetings and written reports/meeting minutes to keep client and project resources advised and aligned. Facilitate project meetings. Implement project documentation governance aligned with company and client requirements. Ensure project data integrity and documentation is accurate, timely and coordinated.
+ Track progress of each project against goals, objectives, approved budgets, approved timelines. Reports status and variances. Creates action plans to meet objectives, budget and schedule.
+ Implement change management routines to assess change requests, make recommendations, secure client approvals, and issue change orders. Assesses change requests to determine impacts to scope, budget, schedule, quality and risk.
+ Demonstrates ability to identify complex project risks, lead constructability reviews, develop risk mitigation and contingency plans, and implement action plans to reduce or eliminate project risks.
+ Manage multi-site portfolio for client.
+ Has a growth mindset for the client and the team built to execute the project/program.
+ Demonstrate a knowledge of projects & project management within the context of business results (business case, larger economic implications, business risk, etc.).
+ Other duties as assigned.
What you'll need
Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future.
+ Bachelor's degree (BA/BS/BEng/BArch) from College or University in a technical area of study. Prior experience in the pharma, life sciences, or health care industry preferred but not vital as a condition for consideration.
+ 8+ years of progressive experience in design, engineering, or construction management, with 5+ years' experience focused on life science, healthcare or lab facilities which may include biology, cell/gene therapy, chemistry, pharmaceutical, cGMP process manufacturing, agricultural / food science, vivarium, bio-containment, academic research, public health and/or clinical labs.
+ Acts as Subject Matter Expert on design and construction strategies for A/S/M/E/P/P building systems on life science projects and with ability to lead project teams through the decision-making process which result in high value, safe, adaptable, sustainable, flexible, and robust science facilities.
+ Significant experience leading the programming, design, and construction phases on life science projects including laboratory research facilities. Experience with cGMP facilities is a plus.
+ Provide Subject Matter leadership on design and construction strategies for architectural and engineering systems on life science projects with an ability to lead project teams through the decision-making process to deliver high value, safe, responsive, sustainable, flexible, and robust facilities.
+ Knowledge of building codes, standards and building structures for life science facilities.
+ Participate in the growth of CBRE & T&T's Life Sciences Practice Area through industry, marketing, and business development activities. Current participation with community, industry and professional life science organizations is a plus. Relationships with decision-makers at end-user science organizations is a plus.
+ Ability to comprehend, analyze, and interpret complex business documents and respond effectively to critical issues. Ability to make effective and persuasive presentations on various topics to employees, clients, top management and/or public groups. Ability to motivate and negotiate effectively with key employees, top management, and client groups to take desired action.
+ Intermediate skills with Microsoft Office Suite and client control platforms. Ability to read and understand architectural drawings. Knowledge in MS Project, leases, contracts, and construction practices.
+ Ability to solve advanced problems and deal with a variety of options in complex situations. Proven experience in developing strategic solutions for a growing matrix-based multi-industry sales environment. Ability to draw upon the analysis of others and make recommendations that have a direct impact on the company.
+ Ability to forecast and prepare budgets, conduct analysis and prepare or review financial report.
+ Bilingual English - Spanish preferred.
+ License or Certificate in Architecture, Engineering, or Construction Management, PMP (US and/or Canada) and LEED AP preferred.
Disclaimer:
Please be advised that effective January 1, 2025, CBRE Project Management and Turner &Townsend was consolidated into a single global business entity. As a candidate applying for a position, you should be aware that while your initial employment may be with Turner & Townsend PJM US LLC, you will subsequently transfer directly to Turner & Townsend at a date to be determined.
**Equal Employment Opportunity:** CBRE has a long-standing commitment to providing equal employment opportunity to all qualified applicants regardless of race, color, religion, national origin, sex, sexual orientation, gender identity, pregnancy, age, citizenship, marital status, disability, veteran status, political belief, or any other basis protected by applicable law.
**Candidate Accommodations:** CBRE values the differences of all current and prospective employees and recognizes how every employee contributes to our company's success. CBRE provides reasonable accommodations in job application procedures for individuals with disabilities. If you require assistance due to a disability in the application or recruitment process, please submit a request via email at or via telephone at (U.S.) and (Canada).
CBRE, Inc. is an Equal Opportunity and Affirmative Action Employer (Women/Minorities/Persons with Disabilities/US Veterans)
View Now
5
Life Sciences Senior Project Manager - Talent Community
00918 San Juan, Puerto Rico
CBRE
Posted 15 days ago
Job Viewed
Job Description
Life Sciences Senior Project Manager - Talent Community
Job ID
Posted
22-May-2025
Service line
PJM Segment
Role type
Full-time
Areas of Interest
Construction, Project Management
Location(s)
Bayamon - Puerto Rico - United States of America, Caguas - Puerto Rico - United States of America, Carolina - Puerto Rico - United States of America, Coamo - Puerto Rico - United States of America, Fajardo - Puerto Rico - United States of America, Guayama - Puerto Rico - United States of America, Guaynabo - Puerto Rico - United States of America, Luquillo - Puerto Rico - United States of America, Rio Grande - Puerto Rico - United States of America, San Juan - Puerto Rico - United States of America, Vega Baja - Puerto Rico - United States of America
CBRE is using this platform to provide general information to individuals who want to learn more about a career at CBRE. If an opportunity opens that matches your qualifications, we will reach out to you at that time. We are growing a world-class organization with a world-class team and appreciate your interest in CBRE. We welcome you to explore our Careers ( page and apply directly to any positions that interest you. We will not consider the submission of resumes on this platform as an expression of interest in any posted position at CBRE.
**CBRE / Turner and Townsend currently have multiple opportunities within Project Management for our Life Sciences clients in Puerto Rico. We are currently seeking bilingual (Spanish/English) Project Managers with cGMP experience.**
**About The Role**
As a Life Sciences Senior Project Manager you will manage and lead design and construction teams responsible for multi-disciplined real estate / capital project solutions for clients in the Commercial /Life Sciences / Biotech / Pharmaceuticals market sector, with direct accountability for project delivery.
Preferred experience in regulated areas such as imaging, animal studies, laboratories, environmentally-controlled areas, and production areas thus the candidate should be familiar with pharmaceutical current good manufacturing practices (cGMP) including commissioning processes.
The work will include civil, infrastructure, structural, and interior projects in administrative, laboratories, production, and warehouse areas, regulated and non-regulated environments, and plant utility areas.
What you'll do
+ Experience in all facets of project management (resources, budget, schedule, procurement, quality & risk assessment) for projects including planning, design, construction, occupancy, and closeout.
+ Experience interpreting and applying knowledge on sophisticated documents affecting real estate / construction projects, including but not limited to: agreements/contracts, leases, work letters, project charters, architectural and engineering design, construction documentation, and construction administration / management practices.
+ Interfaces directly with clients to define project requirements, prepare scope of work, project delivery resource requirements, oversee cost estimate & budget preparation, review cash flow, work plan schedule & milestones, quality control, and risk identification.
+ Experience with Collaborative, Integrated, and Lean Project Delivery methods is a plus.
+ Identify project delivery resources from pre-qualified lists, or through individual project qualification process; conducts standard to complex request for proposals; completes bid analysis; leads evaluation interviews, recommends resources to clients. Lead project delivery resources/team (typically larger more experienced team) providing project mentorship and direction to achieve project goals
+ Implement communication plan for meetings and written reports/meeting minutes to keep client and project resources advised and aligned. Facilitate project meetings. Implement project documentation governance aligned with company and client requirements. Ensure project data integrity and documentation is accurate, timely and coordinated.
+ Track progress of each project against goals, objectives, approved budgets, approved timelines. Reports status and variances. Creates action plans to meet objectives, budget and schedule.
+ Implement change management routines to assess change requests, make recommendations, secure client approvals, and issue change orders. Assesses change requests to determine impacts to scope, budget, schedule, quality and risk.
+ Demonstrates ability to identify complex project risks, lead constructability reviews, develop risk mitigation and contingency plans, and implement action plans to reduce or eliminate project risks.
+ Manage multi-site portfolio for client.
+ Has a growth mindset for the client and the team built to execute the project/program.
+ Demonstrate a knowledge of projects & project management within the context of business results (business case, larger economic implications, business risk, etc.).
+ Other duties as assigned.
What you'll need
Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future.
+ Bachelor's degree (BA/BS/BEng/BArch) from College or University in a technical area of study. Prior experience in the pharma, life sciences, or health care industry preferred but not vital as a condition for consideration.
+ 8+ years of progressive experience in design, engineering, or construction management, with 5+ years' experience focused on life science, healthcare or lab facilities which may include biology, cell/gene therapy, chemistry, pharmaceutical, cGMP process manufacturing, agricultural / food science, vivarium, bio-containment, academic research, public health and/or clinical labs.
+ Acts as Subject Matter Expert on design and construction strategies for A/S/M/E/P/P building systems on life science projects and with ability to lead project teams through the decision-making process which result in high value, safe, adaptable, sustainable, flexible, and robust science facilities.
+ Significant experience leading the programming, design, and construction phases on life science projects including laboratory research facilities. Experience with cGMP facilities is a plus.
+ Provide Subject Matter leadership on design and construction strategies for architectural and engineering systems on life science projects with an ability to lead project teams through the decision-making process to deliver high value, safe, responsive, sustainable, flexible, and robust facilities.
+ Knowledge of building codes, standards and building structures for life science facilities.
+ Participate in the growth of CBRE & T&T's Life Sciences Practice Area through industry, marketing, and business development activities. Current participation with community, industry and professional life science organizations is a plus. Relationships with decision-makers at end-user science organizations is a plus.
+ Ability to comprehend, analyze, and interpret complex business documents and respond effectively to critical issues. Ability to make effective and persuasive presentations on various topics to employees, clients, top management and/or public groups. Ability to motivate and negotiate effectively with key employees, top management, and client groups to take desired action.
+ Intermediate skills with Microsoft Office Suite and client control platforms. Ability to read and understand architectural drawings. Knowledge in MS Project, leases, contracts, and construction practices.
+ Ability to solve advanced problems and deal with a variety of options in complex situations. Proven experience in developing strategic solutions for a growing matrix-based multi-industry sales environment. Ability to draw upon the analysis of others and make recommendations that have a direct impact on the company.
+ Ability to forecast and prepare budgets, conduct analysis and prepare or review financial report.
+ Bilingual English - Spanish preferred.
+ License or Certificate in Architecture, Engineering, or Construction Management, PMP (US and/or Canada) and LEED AP preferred.
Disclaimer:
Please be advised that effective January 1, 2025, CBRE Project Management and Turner &Townsend was consolidated into a single global business entity. As a candidate applying for a position, you should be aware that while your initial employment may be with Turner & Townsend PJM US LLC, you will subsequently transfer directly to Turner & Townsend at a date to be determined.
**Equal Employment Opportunity:** CBRE has a long-standing commitment to providing equal employment opportunity to all qualified applicants regardless of race, color, religion, national origin, sex, sexual orientation, gender identity, pregnancy, age, citizenship, marital status, disability, veteran status, political belief, or any other basis protected by applicable law.
**Candidate Accommodations:** CBRE values the differences of all current and prospective employees and recognizes how every employee contributes to our company's success. CBRE provides reasonable accommodations in job application procedures for individuals with disabilities. If you require assistance due to a disability in the application or recruitment process, please submit a request via email at or via telephone at (U.S.) and (Canada).
CBRE, Inc. is an Equal Opportunity and Affirmative Action Employer (Women/Minorities/Persons with Disabilities/US Veterans)
Job ID
Posted
22-May-2025
Service line
PJM Segment
Role type
Full-time
Areas of Interest
Construction, Project Management
Location(s)
Bayamon - Puerto Rico - United States of America, Caguas - Puerto Rico - United States of America, Carolina - Puerto Rico - United States of America, Coamo - Puerto Rico - United States of America, Fajardo - Puerto Rico - United States of America, Guayama - Puerto Rico - United States of America, Guaynabo - Puerto Rico - United States of America, Luquillo - Puerto Rico - United States of America, Rio Grande - Puerto Rico - United States of America, San Juan - Puerto Rico - United States of America, Vega Baja - Puerto Rico - United States of America
CBRE is using this platform to provide general information to individuals who want to learn more about a career at CBRE. If an opportunity opens that matches your qualifications, we will reach out to you at that time. We are growing a world-class organization with a world-class team and appreciate your interest in CBRE. We welcome you to explore our Careers ( page and apply directly to any positions that interest you. We will not consider the submission of resumes on this platform as an expression of interest in any posted position at CBRE.
**CBRE / Turner and Townsend currently have multiple opportunities within Project Management for our Life Sciences clients in Puerto Rico. We are currently seeking bilingual (Spanish/English) Project Managers with cGMP experience.**
**About The Role**
As a Life Sciences Senior Project Manager you will manage and lead design and construction teams responsible for multi-disciplined real estate / capital project solutions for clients in the Commercial /Life Sciences / Biotech / Pharmaceuticals market sector, with direct accountability for project delivery.
Preferred experience in regulated areas such as imaging, animal studies, laboratories, environmentally-controlled areas, and production areas thus the candidate should be familiar with pharmaceutical current good manufacturing practices (cGMP) including commissioning processes.
The work will include civil, infrastructure, structural, and interior projects in administrative, laboratories, production, and warehouse areas, regulated and non-regulated environments, and plant utility areas.
What you'll do
+ Experience in all facets of project management (resources, budget, schedule, procurement, quality & risk assessment) for projects including planning, design, construction, occupancy, and closeout.
+ Experience interpreting and applying knowledge on sophisticated documents affecting real estate / construction projects, including but not limited to: agreements/contracts, leases, work letters, project charters, architectural and engineering design, construction documentation, and construction administration / management practices.
+ Interfaces directly with clients to define project requirements, prepare scope of work, project delivery resource requirements, oversee cost estimate & budget preparation, review cash flow, work plan schedule & milestones, quality control, and risk identification.
+ Experience with Collaborative, Integrated, and Lean Project Delivery methods is a plus.
+ Identify project delivery resources from pre-qualified lists, or through individual project qualification process; conducts standard to complex request for proposals; completes bid analysis; leads evaluation interviews, recommends resources to clients. Lead project delivery resources/team (typically larger more experienced team) providing project mentorship and direction to achieve project goals
+ Implement communication plan for meetings and written reports/meeting minutes to keep client and project resources advised and aligned. Facilitate project meetings. Implement project documentation governance aligned with company and client requirements. Ensure project data integrity and documentation is accurate, timely and coordinated.
+ Track progress of each project against goals, objectives, approved budgets, approved timelines. Reports status and variances. Creates action plans to meet objectives, budget and schedule.
+ Implement change management routines to assess change requests, make recommendations, secure client approvals, and issue change orders. Assesses change requests to determine impacts to scope, budget, schedule, quality and risk.
+ Demonstrates ability to identify complex project risks, lead constructability reviews, develop risk mitigation and contingency plans, and implement action plans to reduce or eliminate project risks.
+ Manage multi-site portfolio for client.
+ Has a growth mindset for the client and the team built to execute the project/program.
+ Demonstrate a knowledge of projects & project management within the context of business results (business case, larger economic implications, business risk, etc.).
+ Other duties as assigned.
What you'll need
Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future.
+ Bachelor's degree (BA/BS/BEng/BArch) from College or University in a technical area of study. Prior experience in the pharma, life sciences, or health care industry preferred but not vital as a condition for consideration.
+ 8+ years of progressive experience in design, engineering, or construction management, with 5+ years' experience focused on life science, healthcare or lab facilities which may include biology, cell/gene therapy, chemistry, pharmaceutical, cGMP process manufacturing, agricultural / food science, vivarium, bio-containment, academic research, public health and/or clinical labs.
+ Acts as Subject Matter Expert on design and construction strategies for A/S/M/E/P/P building systems on life science projects and with ability to lead project teams through the decision-making process which result in high value, safe, adaptable, sustainable, flexible, and robust science facilities.
+ Significant experience leading the programming, design, and construction phases on life science projects including laboratory research facilities. Experience with cGMP facilities is a plus.
+ Provide Subject Matter leadership on design and construction strategies for architectural and engineering systems on life science projects with an ability to lead project teams through the decision-making process to deliver high value, safe, responsive, sustainable, flexible, and robust facilities.
+ Knowledge of building codes, standards and building structures for life science facilities.
+ Participate in the growth of CBRE & T&T's Life Sciences Practice Area through industry, marketing, and business development activities. Current participation with community, industry and professional life science organizations is a plus. Relationships with decision-makers at end-user science organizations is a plus.
+ Ability to comprehend, analyze, and interpret complex business documents and respond effectively to critical issues. Ability to make effective and persuasive presentations on various topics to employees, clients, top management and/or public groups. Ability to motivate and negotiate effectively with key employees, top management, and client groups to take desired action.
+ Intermediate skills with Microsoft Office Suite and client control platforms. Ability to read and understand architectural drawings. Knowledge in MS Project, leases, contracts, and construction practices.
+ Ability to solve advanced problems and deal with a variety of options in complex situations. Proven experience in developing strategic solutions for a growing matrix-based multi-industry sales environment. Ability to draw upon the analysis of others and make recommendations that have a direct impact on the company.
+ Ability to forecast and prepare budgets, conduct analysis and prepare or review financial report.
+ Bilingual English - Spanish preferred.
+ License or Certificate in Architecture, Engineering, or Construction Management, PMP (US and/or Canada) and LEED AP preferred.
Disclaimer:
Please be advised that effective January 1, 2025, CBRE Project Management and Turner &Townsend was consolidated into a single global business entity. As a candidate applying for a position, you should be aware that while your initial employment may be with Turner & Townsend PJM US LLC, you will subsequently transfer directly to Turner & Townsend at a date to be determined.
**Equal Employment Opportunity:** CBRE has a long-standing commitment to providing equal employment opportunity to all qualified applicants regardless of race, color, religion, national origin, sex, sexual orientation, gender identity, pregnancy, age, citizenship, marital status, disability, veteran status, political belief, or any other basis protected by applicable law.
**Candidate Accommodations:** CBRE values the differences of all current and prospective employees and recognizes how every employee contributes to our company's success. CBRE provides reasonable accommodations in job application procedures for individuals with disabilities. If you require assistance due to a disability in the application or recruitment process, please submit a request via email at or via telephone at (U.S.) and (Canada).
CBRE, Inc. is an Equal Opportunity and Affirmative Action Employer (Women/Minorities/Persons with Disabilities/US Veterans)
View Now
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6
Senior Principal Regulatory Affairs Specialist
00918 San Juan, Puerto Rico
Bausch + Lomb
Posted 15 days ago
Job Viewed
Job Description
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
**Objectives:**
Responsible for the overall product strategy, reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management for consumer products (Rx/OTC, OTC Monograph, Nutritional, and Cosmetics).
**Responsibilities:**
+ Interpret Regulatory Authority policies, regulations and guidances and correctly apply them, as appropriate
+ Provide technical expertise internally and/or externally as subject matter expert
+ Participate in external industry forums (such as trade associations, committees and regulatory boards) as required and influence externally
+ Represent BNL in external committees and boards as required
+ Coach and mentor individuals on subject matter expertise
+ Provide guidance and direction regarding regulatory strategy to project teams
+ Participate in assigned due diligence activities for business development and acquisitions
+ Utilize multiple regulatory databases to ensure the stringent accuracy of information for creation of cosmetics, OTC Drug Facts and nutritional/natural health products in the US and/or Canada
+ Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling, adpromo domains
+ Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC products and dietary supplements
+ Plan, author, review, and coordinate high-quality submission components (including complex variations such as PAS, group supplements, site transfers, and supplier changes) for IND, NDA, ANDA amendments/supplements
+ Review raw materials and formulations, provide advice to product development teams and give guidance on potential regulatory compliance issues
+ Point of contact with Health Authorities and ability to manage the relationship with Health Authorities
**Qualifications:**
+ Bachelor's degree or equivalent; Master's degree preferred
+ Minimum of 8 years in Regulatory Affairs with experience in the consumer product (Rx/OTC, OTC Monograph, Nutritional, and/or Cosmetics) regulated environment
+ Thorough understanding of regulatory processes and information systems.
+ Demonstrated ability in analytical reasoning and critical thinking skills
+ Ability to influence internal and external key stakeholders and KOL's
+ Ability to handle multiple tasks and meet deadlines
+ Strong capability to contribute in a team environment
+ Ability to support internal/external business stakeholders
+ Excellent organizational and communication skills; both oral and written
+ Strong interpersonal skills with the ability to influence others in a positive and effective manner
+ Demonstrated ability to contribute to a continuous learning and process improvement environment
+ Capacity to react quickly and decisively in unexpected situations
+ Ability to author pre-market and post market registration documents
+ Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
+ Focused ability to influence operational excellence and performance metrics
+ Risk adverse where needed with the ability to identify potential solutions to complex problems
+ Capability to effectively work independently
+ Experience in practical understanding, interpretation, and application of US regulatory requirements for cosmetic products (MoCRA), including state-specific requirements and CPSC requirements preferred
+ Experiencewith innovative approaches and general regulatory requirements for Rx to OTC switch preferred
+ Ability to interpret Regulatory Authority policies, regulations and guidances and correctly apply them, as appropriate
+ Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
+ Ability to take innovative ideas to promote a successful regulatory submission and increase the probability of regulatory approval.
+ Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
+ Excellent communication skills; both oral and written
+ Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business.
+ Capacity to react quickly and decisively in unexpected situations
+ Ability to influence external regulatory stakeholders and shape the external regulatory environment.
+ Advanced Project Management / leadership experience with the ability to influence team members that are not within their reporting structure
+ The ability to work effectively with key national opinion leaders, and advisory boards
+ Working knowledge of FDA regulations / Code of Federal Regulations (CFR)
**We offer competitive salary & excellent benefits including:**
+ Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
+ 401K Plan with company match and ongoing company contribution
+ Paid time off vacation (3 weeks - prorated upon hire), floating holidays and sick time
+ Employee Stock Purchase Plan with company match
+ Employee Incentive Bonus
+ Tuition Reimbursement (select degrees)
+ Ongoing performance feedback and annual compensation review
This position may be available in the following location(s):((location_obj))
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $120,000 and $180,000 per year. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please readBausch + Lomb's Job Offer Fraud Statement ( .
Our Benefit Programs: Employee Benefits: Bausch + Lomb ( must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
**Objectives:**
Responsible for the overall product strategy, reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management for consumer products (Rx/OTC, OTC Monograph, Nutritional, and Cosmetics).
**Responsibilities:**
+ Interpret Regulatory Authority policies, regulations and guidances and correctly apply them, as appropriate
+ Provide technical expertise internally and/or externally as subject matter expert
+ Participate in external industry forums (such as trade associations, committees and regulatory boards) as required and influence externally
+ Represent BNL in external committees and boards as required
+ Coach and mentor individuals on subject matter expertise
+ Provide guidance and direction regarding regulatory strategy to project teams
+ Participate in assigned due diligence activities for business development and acquisitions
+ Utilize multiple regulatory databases to ensure the stringent accuracy of information for creation of cosmetics, OTC Drug Facts and nutritional/natural health products in the US and/or Canada
+ Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling, adpromo domains
+ Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC products and dietary supplements
+ Plan, author, review, and coordinate high-quality submission components (including complex variations such as PAS, group supplements, site transfers, and supplier changes) for IND, NDA, ANDA amendments/supplements
+ Review raw materials and formulations, provide advice to product development teams and give guidance on potential regulatory compliance issues
+ Point of contact with Health Authorities and ability to manage the relationship with Health Authorities
**Qualifications:**
+ Bachelor's degree or equivalent; Master's degree preferred
+ Minimum of 8 years in Regulatory Affairs with experience in the consumer product (Rx/OTC, OTC Monograph, Nutritional, and/or Cosmetics) regulated environment
+ Thorough understanding of regulatory processes and information systems.
+ Demonstrated ability in analytical reasoning and critical thinking skills
+ Ability to influence internal and external key stakeholders and KOL's
+ Ability to handle multiple tasks and meet deadlines
+ Strong capability to contribute in a team environment
+ Ability to support internal/external business stakeholders
+ Excellent organizational and communication skills; both oral and written
+ Strong interpersonal skills with the ability to influence others in a positive and effective manner
+ Demonstrated ability to contribute to a continuous learning and process improvement environment
+ Capacity to react quickly and decisively in unexpected situations
+ Ability to author pre-market and post market registration documents
+ Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
+ Focused ability to influence operational excellence and performance metrics
+ Risk adverse where needed with the ability to identify potential solutions to complex problems
+ Capability to effectively work independently
+ Experience in practical understanding, interpretation, and application of US regulatory requirements for cosmetic products (MoCRA), including state-specific requirements and CPSC requirements preferred
+ Experiencewith innovative approaches and general regulatory requirements for Rx to OTC switch preferred
+ Ability to interpret Regulatory Authority policies, regulations and guidances and correctly apply them, as appropriate
+ Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
+ Ability to take innovative ideas to promote a successful regulatory submission and increase the probability of regulatory approval.
+ Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
+ Excellent communication skills; both oral and written
+ Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business.
+ Capacity to react quickly and decisively in unexpected situations
+ Ability to influence external regulatory stakeholders and shape the external regulatory environment.
+ Advanced Project Management / leadership experience with the ability to influence team members that are not within their reporting structure
+ The ability to work effectively with key national opinion leaders, and advisory boards
+ Working knowledge of FDA regulations / Code of Federal Regulations (CFR)
**We offer competitive salary & excellent benefits including:**
+ Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
+ 401K Plan with company match and ongoing company contribution
+ Paid time off vacation (3 weeks - prorated upon hire), floating holidays and sick time
+ Employee Stock Purchase Plan with company match
+ Employee Incentive Bonus
+ Tuition Reimbursement (select degrees)
+ Ongoing performance feedback and annual compensation review
This position may be available in the following location(s):((location_obj))
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $120,000 and $180,000 per year. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please readBausch + Lomb's Job Offer Fraud Statement ( .
Our Benefit Programs: Employee Benefits: Bausch + Lomb ( must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
View Now
7
Senior Principal Regulatory Affairs Specialist
00918 San Juan, Puerto Rico
Bausch + Lomb
Posted 15 days ago
Job Viewed
Job Description
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
**Objectives:**
Lead and execute global regulatory strategies for development programs and marketed products across CMC and clinical/non-clinical, labeling, adpromo areas. Serve as a strategic advisor to project teams, ensuring regulatory compliance, influencing key stakeholders, and optimizing business outcomes.
**Responsibilities:**
+ Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling, adpromo domains.
+ Provide technical expertise and regulatory direction to project teams throughout the product lifecycle.
+ Proactively communicate strategy, risks, and critical issues to stakeholders and senior leadership.
+ Influence internal and external stakeholders, including Key Opinion Leaders (KOLs), to achieve strategic objectives.
+ Serve as primary regulatory point of contact with Health Authorities and manage ongoing relationships.
+ Participate in assigned due diligence activities for business development and acquisitions.
+ Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions.
+ Plan, author, review, and coordinate high-quality submission components (including complex variations such as PAS, group supplements, site transfers, and supplier changes) for IND, NDA, ANDAs and amendments/supplements.
+ Serve as RA representative on facility/site Local Change Management Boards.
+ Ensure operational excellence, compliance, and timely execution of deliverables.
+ Drive regulatory strategies for clinical, non-clinical, CMC and labeling development plans, ensuring alignment with global requirements.
+ Provide guidance on risk assessment, clinical trial design implications, and regulatory pathways.
+ Support interactions with Health Authorities for development programs.
+ Ensure high-quality submissions by proofreading and checking documents for accuracy and consistency.
+ Contribute to continuous learning, process improvement, and knowledge-sharing initiatives.
+ Mentor and coach team members in regulatory strategy and submission excellence.
+ Monitor and report on performance metrics to drive operational effectiveness.
+ Participate in external forums, regulatory boards, and committees to influence regulatory policies and industry standards.
**Qualifications:**
+ Bachelor degree or equivalent, Master degree preferred
+ Minimum of 8 years in Regulatory Affairs or relevant experience in a regulated environment
+ Ability to interpret Regulatory Authority policies, regulations and guidances and correctly apply them as appropriate
+ Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
+ Ability to take innovative ideas to promote a successful regulatory submission and increase the probability of regulatory approval
+ Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
+ Strong interpersonal skills with the ability to influence others in a positive and effective manner
+ Demonstrated ability to contribute to a continuous learning and process improvement environment
+ Excellent communication skills; both oral and written
+ Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business
+ Capacity to react quickly and decisively in unexpected situations
+ Ability to influence external regulatory stakeholders and shape the external regulatory environment
+ Advanced Project Management / leadership experience with the ability to influence team members that are not within their reporting structure
+ The ability to work with key national opinion leaders, and advisory boards
**We offer competitive salary & excellent benefits including:**
+ Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
+ 401K Plan with company match and ongoing company contribution
+ Paid time off vacation (3 weeks - prorated upon hire), floating holidays and sick time
+ Employee Stock Purchase Plan with company match
+ Employee Incentive Bonus
+ Tuition Reimbursement (select degrees)
+ Ongoing performance feedback and annual compensation review
This position may be available in the following location(s): ((location_obj))
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $120,000 to $180,000. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please readBausch + Lomb's Job Offer Fraud Statement ( .
Our Benefit Programs: Employee Benefits: Bausch + Lomb ( must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
**Objectives:**
Lead and execute global regulatory strategies for development programs and marketed products across CMC and clinical/non-clinical, labeling, adpromo areas. Serve as a strategic advisor to project teams, ensuring regulatory compliance, influencing key stakeholders, and optimizing business outcomes.
**Responsibilities:**
+ Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling, adpromo domains.
+ Provide technical expertise and regulatory direction to project teams throughout the product lifecycle.
+ Proactively communicate strategy, risks, and critical issues to stakeholders and senior leadership.
+ Influence internal and external stakeholders, including Key Opinion Leaders (KOLs), to achieve strategic objectives.
+ Serve as primary regulatory point of contact with Health Authorities and manage ongoing relationships.
+ Participate in assigned due diligence activities for business development and acquisitions.
+ Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions.
+ Plan, author, review, and coordinate high-quality submission components (including complex variations such as PAS, group supplements, site transfers, and supplier changes) for IND, NDA, ANDAs and amendments/supplements.
+ Serve as RA representative on facility/site Local Change Management Boards.
+ Ensure operational excellence, compliance, and timely execution of deliverables.
+ Drive regulatory strategies for clinical, non-clinical, CMC and labeling development plans, ensuring alignment with global requirements.
+ Provide guidance on risk assessment, clinical trial design implications, and regulatory pathways.
+ Support interactions with Health Authorities for development programs.
+ Ensure high-quality submissions by proofreading and checking documents for accuracy and consistency.
+ Contribute to continuous learning, process improvement, and knowledge-sharing initiatives.
+ Mentor and coach team members in regulatory strategy and submission excellence.
+ Monitor and report on performance metrics to drive operational effectiveness.
+ Participate in external forums, regulatory boards, and committees to influence regulatory policies and industry standards.
**Qualifications:**
+ Bachelor degree or equivalent, Master degree preferred
+ Minimum of 8 years in Regulatory Affairs or relevant experience in a regulated environment
+ Ability to interpret Regulatory Authority policies, regulations and guidances and correctly apply them as appropriate
+ Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
+ Ability to take innovative ideas to promote a successful regulatory submission and increase the probability of regulatory approval
+ Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
+ Strong interpersonal skills with the ability to influence others in a positive and effective manner
+ Demonstrated ability to contribute to a continuous learning and process improvement environment
+ Excellent communication skills; both oral and written
+ Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business
+ Capacity to react quickly and decisively in unexpected situations
+ Ability to influence external regulatory stakeholders and shape the external regulatory environment
+ Advanced Project Management / leadership experience with the ability to influence team members that are not within their reporting structure
+ The ability to work with key national opinion leaders, and advisory boards
**We offer competitive salary & excellent benefits including:**
+ Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
+ 401K Plan with company match and ongoing company contribution
+ Paid time off vacation (3 weeks - prorated upon hire), floating holidays and sick time
+ Employee Stock Purchase Plan with company match
+ Employee Incentive Bonus
+ Tuition Reimbursement (select degrees)
+ Ongoing performance feedback and annual compensation review
This position may be available in the following location(s): ((location_obj))
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $120,000 to $180,000. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please readBausch + Lomb's Job Offer Fraud Statement ( .
Our Benefit Programs: Employee Benefits: Bausch + Lomb ( must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
View Now
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