249 Pharmaceutical jobs in Columbus
Executive Director, Clinical Pharmacology
Posted 6 days ago
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Job Description
Executive Director, Clinical Pharmacology
About the Company
Successful therapeutics company specializing in machine learning-powered biomedicines
Industry
Biotechnology
Type
Privately Held, VC-backed
Founded
2018
Employees
201-500
Funding
$200+ million
Categories
- Biotechnology
- Health Care
- Medical
- Product Research
About the Role
The Company is seeking an Executive Director of Clinical Pharmacology to lead the strategy and execution of global Ph2/3 studies, with a focus on respiratory indications and global regulatory alignment. The successful candidate will be the subject matter expert for regulatory agency interactions on clinical pharmacology topics, including INDs, BLAs, and pediatric plans. This role involves designing and overseeing modeling and simulation efforts, leading the development of global PK, PK/PD, and exposure-response strategies, and collaborating with cross-functional teams to optimize clinical trial design and endpoints. The Executive Director will also be responsible for driving the pediatric strategy, guiding bioanalytical strategy, and providing clinical pharmacology oversight across development stages.
The ideal candidate will have a PhD, PharmD, or MD in a related field, with at least 12 years' of experience in clinical pharmacology within biotech or pharma, including late-stage development and global regulatory interactions. A proven track record in leading clinical pharmacology deliverables in regulatory agency engagements, particularly with the FDA, EMA, PMDA, and NMPA, is essential. Deep expertise in PK/PD modeling and simulation, strong background in pediatric development, and experience in supporting respiratory indications are highly valued. The role also requires excellent communication skills, the ability to build and lead a high-performing team, and a commitment to fostering scientific excellence and collaborative innovation.
Hiring Manager Title
Head of Clinical Pharmacology
Travel Percent
Less than 10%
Functions
- Medical Care/Hospital Administration
- Non-Profit Management
Pharmaceutical Packaging Technician - 1st Shift 7am to 3:30pm
Posted 8 days ago
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Job Description
Job DetailsJob LocationColumbus OH - Columbus, OHDescriptionPurpose:At Safecor Health, our purpose is to help deliver even better care to even more people. As a key member of our team, you will contribute to the safe, high-quality delivery of medications to patients in hospitals. Your work in packaging and barcoding services plays a critical role in the healthcare supply chain, ensuring that medications are properly prepared and available when needed most.Vision:We strive to be the best partner in solving the most important and complex challenges of supply chain, packaging, logistics, and the delivery of unit-dose medicines. By joining our team, you'll help us push boundaries to provide top-tier solutions that make a real difference in patient care.Values:At the heart of everything we do are our core values of Care, Commitment, and Excellence. As a Packaging Technician, you'll embody these values in your work by showing dedication to the well-being of patients, taking pride in the quality of your work, and consistently striving for excellence in all that you do.Position Overview:As a Packaging Technician, you will be responsible for applying a disciplined approach to packaging and barcoding unit-dose medications in our production facilities. You'll play an essential role in ensuring our hospital customers have access to safe, accurate, and high-quality medications to deliver the best care to their patients.This includes operating packaging equipment to repackage oral solids into unit-dose formats, filling cups, and syringes as specified, and maintaining the equipment used in daily operations. Your ability to troubleshoot and perform regular maintenance on equipment will be vital to keeping the workflow running smoothly.Responsibilities:Unit-Dose Packaging: Perform all unit-dose medication packaging, completing daily orders as required.Workstation Maintenance: Ensure that your workstation is stocked with all supplies needed to fulfill services efficiently.Equipment Maintenance: Conduct daily preventative maintenance on packaging equipment, including performing necessary adjustments and troubleshooting.Labeling: Generate accurate packaging labels in accordance with specifications and verification procedures, adhering to standard operating procedures.Compliance: Follow all standard operating procedures (SOP)in line with current Good Manufacturing Practices (cGMP) and relevant regulatory standards to maintain safety and quality.QualificationsWhat you bring to the table:Qualifications:High school diploma or equivalent required; technical training in packaging or related field preferred.Experience in a packaging or manufacturing environment, especially in the pharmaceutical or healthcare industry, is a plus.Strong attention to detail and ability to adhere to strict regulatory standards.Ability to operate packaging equipment and perform basic maintenance and troubleshooting.Strong organizational skills and ability to work efficiently in a fast-paced environment.A commitment to quality, safety, and patient care, with a desire to continuously improve processes and outcomes.Why Join Us?At Safecor Health, you'll be part of a dynamic team that is dedicated to delivering on our purpose of helping others through care, commitment, and excellence. Join us and make a meaningful difference in the lives of people who rely on the medications we help deliver.How We Take Care of You And Your FamilyThe meaningful work you do helps our customers support their patients, so we'll work hard to support you.Clean and safe work environmentMedical, dental and vision insuranceCompany-paid life insuranceHealth savings accountPaid time off (PTO)Earned sick time (EST)Holiday payWeekly pay401kOpportunities for internal promotionMonthly employee appreciation meals
Clinical Research Coordinator II - RI Academic Affairs & Research Dev
Posted 11 days ago
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Job Description
With supervision, the CRC will engage in the enrollment, recruitment, retention of research participants, and other tasks as needed. The CRC will conduct clinical interviews for children and adults, obtain mental health history, and review reported suicidal ideation/behavior to determine if further intervention is indicated. They will work on projects focused on youth mental health, including school-based programming. Travel to school research sites required. Bachelor's degree in social science field and previous research experience or work in the mental health field preferred. Effective customer service, communication, organization, and attention to detail required.
Typical hours: Mon-Fri 8a-4:30p, one late day/week 12p-8:30p. Hours subject to change dependent on project needs.
Job DescriptionManages elements of a clinical study to meet protocol obligations while following ICH/GCP guidelines and departmental/institutional standard operating procedures. Coordinates start-up activities, launch activities, day-to-day management of a study, and study closure activities. Trains and mentors other CRC's to ensure consistency in study management activities.
Essential Functions- Conducts clinical studies as outlined in the study protocol; discerns critical elements of the protocol to ensure subject safety throughout study; adheres to good clinical practices.
- Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects' rights through institutional IRB, federal and state regulations; Ensures the subject meets inclusion/exclusion criteria; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate;
- Coordinates, and schedules subject study visits with other hospital services and the PI/sub-I; manages protocol required data; performs study procedures according to recognized skill level and certifications and within the local and federal regulations and guidelines; collects, processes and ships human specimens for use in research studies
- Identifies study implementation and/or study management issues and works with the study team to develop and implement solutions to ensure study progress and success
- Assists with the study recruitment plan and provides input into the study budget; manages all screening, enrollment and study participation logs; completes recruitment summary at study termination.
- Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; and conducts accurate and timely subject data collection,
- Assists with study database development to maintain study data in de-identified format, according to recognized skill level; completes Case Report Forms (CRF's) and ensures CRF's are completed prior to monitor visits.
- Educates other study personnel with regards to study-specific responsibilities and keeps written documentation of this training.
- Alerts the investigator when the subject's safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
- Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binder.
- Assists the principal investigator in the preparation of scientific publications and grant proposals.
- Associate's degree or equivalent work-related experience, required.
- BA/BS, preferred.
(not specified)
CertificationsCRA/CRC certification, preferred.
Skills- Understanding of medical terminology and clinical trials preferred.
- Working knowledge of PCs and word processing and data management software.
- Demonstrated analytical skills with accuracy and attention to detail.
- Excellent verbal and written communication skills.
- Goal-oriented and self-directive, ability to manage complex projects independently.
- Strong organizational and interpersonal skills.
- Ability to actively participate as a team player.
Eighteen months experience in clinical research or health care field, required.
Physical RequirementsOCCASIONALLY: Cold Temperatures, Driving motor vehicles (work required) *additional testing may be required, Fume /Gases /Vapors, Loud Noises, Reaching above shoulder, Squat/kneel
FREQUENTLY: Bend/twist, Biohazard waste, Blood and/or Bodily Fluids, Chemicals/Medications, Communicable Diseases and/or Pathogens, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Machinery, Patient Equipment, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Pushing / Pulling: 61-100 lbs, Sitting, Standing, Walking
CONTINUOUSLY: Audible speech, Computer skills, Decision Making, Depth perception, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing Far/near
Additional Physical Requirements performed but not listed above: (not specified)
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet
Vice President and Senior Vice President of Global Regulatory Affairs
Posted 11 days ago
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Job Description
Vice President and Senior Vice President of Global Regulatory Affairs About the Company Respected biopharmaceutical company Industry Biotechnology Type Privately Held About the Role The Company is in search of a Vice President/Senior Vice President of Global Regulatory Affairs to join their dedicated team. The successful candidate will be responsible for the management, development, and coordination of the regulatory affairs organization, with a focus on providing global regulatory strategy and ensuring the timely completion of regulatory activities. This leadership role requires a professional with a minimum of 15 years' experience in pharma/biotech regulatory affairs, including a strong background in global regulatory, particularly in the EU and ideally in AP. The role demands a proven track record in leading successful global 505(b)(1) launches, experience with NDA filings, and a deep understanding of regulatory processes. Experience in respiratory and rare diseases is highly valued. Applicants for this position at the company should hold a BA/BS degree, preferably in a health/life sciences or related field, and possess a strong understanding of regulatory authority guidance, including ICH. The role involves acting as the primary regulatory contact with various agencies, providing innovative regulatory approaches, and overseeing regulatory activities for product development and commercial operations. The ideal candidate will have a demonstrated ability to lead and develop regulatory teams, as well as excellent interpersonal, communication, and presentation skills. A proactive, problem-solving attitude, and the ability to work in a dynamic, cross-functional environment are essential. The company is seeking a strategic leader who can influence and inspire, and who is committed to the mission of bringing novel therapies to patients in need. Hiring Manager Title Chief Medical Officer Travel Percent Less than 10% Functions General Management Operations Strategy
Regulatory Compliance Chemist
Posted 12 days ago
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Job Description
About the job Regulatory Compliance Chemist
Regulatory Compliance Chemist needs Organic Chemistry or Bachelor's degree with 4 years of industrial experience
Regulatory Compliance Chemist requires:
- Familiarity with reading, interpreting SDS
- Familiarity with Microsoft Office applications, primarily Word, Excel, PowerPoint
- Familiarity with searching Chemical Abstracts / SciFinder, Registry Numbers, Chemical Nomenclature
- Familiarity with organic chemical structures, connecting names to structures
- Excellent communication skills, verbal and written
- Excellent analytical skills relating to interpreting regulations and processes
Masters degree, Organic Chemistry or Bachelor's degree with 4 years of industrial experience
- Expertise with Chemical Abstracts / SciFinder
- Expertise with OSHA regulations relating to chemicals
- Expertise with Access
- Expertise with SAP
- Expertise SharePoint
- Support both R&D and Manufacturing in safety and environmental compliance
- Support internal and external customers in safety and environmental compliance
- Maintenance of chemical records, including, but not limited to, SDS
Senior Statistical Programmer FSP
Posted 12 days ago
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Job Description
Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
Position Overview:
As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Early or Late stage clinical trials. This role is Hybrid office based in PA (Preferred) OR NJ .
Our values
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We believe in applying scientific rigor to reveal the full promise inherent in data.
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We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
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We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
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We prize innovation and seek intelligent solutions using leading-edge technology.
How you will contribute:
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Generating and validating statistical programming deliverables (SDTM, ADAM, TFL's) in Early Development Statistics and PK/PD Modeling and Simulation spanning all therapeutic areas.
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Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
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Production and QC / validation programming
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Generating complex ad-hoc reports utilizing raw data
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Applying strong understanding/experience of Efficacy analysis
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Creating and reviewing submission documents and eCRTs
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Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
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Performing lead duties when called upon
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Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
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Being adaptable and flexible when priorities change.
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
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Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
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At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above.
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Having experience/expertise working on Early Development studiesProgramming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters)
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Develop and validate global programming standards for ADaM datasets.
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Develop and validate global programming standards for efficacy analysis, safety analysis and reporting.
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Design and develop complex programming algorithms.
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Experience in one or more of the following will be preferred: R, SPlus, NonMem.
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Assist project teams in creating SDTM deliverables for Analysis and Reporting (A&R) and submission.
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Support project teams in preparing submission deliverables including use of Pinnacle 21 Enterprise.
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Up-versioning activities to specific versions of SDTM.
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Experience supporting Oncology studies would be a plus.
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Strong SAS data manipulation, analysis and reporting skills.
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Solid experience implementing the latest CDISC SDTM / ADaM standards.
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Knowledge of submission standards CDISC SDTM, Define.XML, SDRG, aCRF.
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Strong QC / validation skills.
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Good ad-hoc reporting skills.
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Proficiency in Efficacy analysis.
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Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials' data.
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Submissions experience utilizing define.xml and other submission documents.
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Excellent analytical & troubleshooting skills.
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Ability to provide quality output and deliverables, in adherence with challenging timelines.
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Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
Regulatory Compliance Chemist
Posted 12 days ago
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Job Description
Lead role in compliance with both chemical regulations and internal chemical documentation processes.
MAJOR DUTIES AND RESPONSIBILITIES
Regulatory Compliance
Support both R&D and Manufacturing in safety and environmental compliance
Support internal and external customers in safety and environmental compliance
Maintenance of chemical records, including, but not limited to, SDS
Assistance with internal processes for chemical documentation
Support corporate ES&H initiatives
Record keeping
Compliance with safety and environmental regulations (OSHA, EPA) and internal practices
BASIC QUALIFICATIONS
Bachelor's degree in chemistry, chemical engineering, or related field
- Certifications: None required
- Familiarity with reading, interpreting SDS
- Familiarity with Microsoft Office applications, primarily Word, Excel, PowerPoint
- Familiarity with searching Chemical Abstracts / SciFinder, Registry Numbers, Chemical Nomenclature
- Familiarity with organic chemical structures, connecting names to structures
- Excellent communication skills, verbal and written
- Excellent analytical skills relating to interpreting regulations and processes
Master's degree, Organic Chemistry or Bachelor's degree with 4 years of industrial experience
- Expertise with Chemical Abstracts / SciFinder
- Expertise with OSHA regulations relating to chemicals
- Expertise with Access
- Expertise with SAP
- Expertise SharePoint
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Senior Consultant, Product Engineering Business Analyst - Pharmacy Systems
Posted 12 days ago
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Job Description
What Product Systems Analysis contributes to Cardinal Health
Commercial Technologies manages the enterprise's portfolio of commercial technologies to maximize the business value of the technologies and enhance the customer experience. This function creates strategies for the portfolio and innovative solutions based on relationships with business leaders, develops back-end solutions and capabilities, and improves the front-end experience.
Product System Analysis serves as a liaison between the business and IT to align product strategies and capabilities, also providing technical business specifications to IT. This job family identifies and analyzes product needs, defines requirements, objectives, and participates in the solutions making process. This job family optimize business processes by leveraging the functionality of the technology and product solution.
Responsibilities
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Specialize in understanding our digital specialty and commercial pharmacies operations
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Partner with engineering team members to understand integration capabilities
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Attend customer meetings, listen and analyze customer needs, and present possible solutions to stakeholders and define the requirements
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Meet with stakeholders, analyze business needs, and communicate to engineering teams
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Set clear expectations with stakeholders
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Ensure timely delivery of deliverables
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Bring a strategic vision to Cardinal Health
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Ability to gather and document requirements from multiple internal and external clients and stakeholders, such as pharmacy operations, access and patient support, etc
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Able to deliver requirements in the format required by engineering teams
Qualifications
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Bachelor's degree in related field, or equivalent work experience, preferred
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8-12 years of experience, preferred
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5+ years of pharmacy systems experience
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Experience within specialty pharmacy desired
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Experience with digital pharmacies highly desired
What is expected of you and others at this level
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Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
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Participates in the development of policies and procedures to achieve specific goals
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Recommends new practices, processes, metrics, or models
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Works on or may lead complex projects of large scope
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Projects may have significant and long-term impact
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Provides solutions which may set precedent
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Independently determines method for completion of new projects
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Receives guidance on overall project objectives
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Acts as a mentor to less experienced colleagues
Anticipated salary range: $103,500 - $147,900
Bonus eligible: Yes
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
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Medical, dental and vision coverage
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Paid time off plan
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Health savings account (HSA)
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401k savings plan
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Access to wages before pay day with myFlexPay
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Flexible spending accounts (FSAs)
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Short- and long-term disability coverage
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Work-Life resources
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Paid parental leave
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Healthy lifestyle programs
Application window anticipated to close: 06/17/2025 *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.
#LI-Remote
#LI-AP4
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 (
Regulatory Affairs Specialist - Post Market
Posted 12 days ago
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Job Description
Regulatory Affairs Specialist - Post Market - req1434
OVERVIEW
Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is responsible for complaint handling, coordination of product recalls, FMI processes, processing electronic submissions and state registrations.
RESPONSIBILITIES
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Remote position, west coast hours mandatory
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Coordinate the complaint handling process to include processing of reportable events
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Provide information as requested for the filing of FDA recalls
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Coordinate FMI process, including monitoring and reporting status and completion
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Process electronic submissions (e.g. 3500A, 2579, Product Reports, Annual Reports)
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Coordinate state registrations, including monitoring regulations and preparing and submitting documentation to each state as required
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As requested, write/review CMSU policies, procedures and guidance documents incorporating regulatory requirements/actions
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Assist in maintaining proper preparedness for State or Federal (FDA) authorities
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Represent interests of RA in cross functional teams as needed
#LI-Remote
#LI-NA1
QUALIFICATIONS
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Excellent interpersonal, communication, and organizational skills
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Ability to develop and maintain effective working relationships internally and externally
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Good PC skills, including MS Word, Excel, Oracle, Sales Force, etc.
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2 Years Regulatory Affairs experience in medical device industry required
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Minimum Education Level: 2 Year / Associate's Degree
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4 Year/ Bachelor's Degree (STEM) preferred
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Pay Information: Min. salary of $72,000 to max $116,100 (annual equivalency)
About us!
Canon Medical Systems USA, Inc., a world leader in diagnostic imaging, is in search of qualified candidates to fill our open positions. Canon Medical Systems offers a competitive salary and benefits package, we support a diverse workplace and are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, sexual orientation, gender identity, religion, national origin, protected veteran status, or on the basis of disability. We invite you to join and become part of our Canon family.
Senior Director, Global Clinical Development CNS
Posted 12 days ago
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Job Description
Position Summary
The purpose of this position is to lead the clinical development activities in support of domestic and international clinical development initiatives.
The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities.
The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA and/or Global filings.
Key Job Responsibilities
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Conceives, implements, and analyzes drug development programs, including:
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Understanding pharmacology of drugs and unmet medical needs.
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Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy.
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Working with experts and consultants in the field to refine a clinical development strategy.
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Designing clinical trials for the purpose of meeting specific objectives.
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Anticipating and addressing future commercial and clinical development needs, based on the clinicalcharacter of the compound.
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Implements clinical development programs, including:
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Co-authoring global clinical development plans with all practical elements.
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Leading and motivating the clinical development team to operationalize the clinical develop strategy,i.e., clinical trials management.
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Partnering with internal and external clinical experts and consultants to optimize the scientific integrity of the methodology and ensure the safety of clinical subjects.
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Leading clinical trial projects to ensure all aspects of the clinical trial project plan (e.g., enrollment, database lock) are achieved on time and with the highest quality.
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Developing and leading formal presentations of results to the medical community, in written, verbal, andvisual formats.
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Analyzes and interprets the results of clinical programs in collaboration with clinical, biometric and clinical pharmacology experts.
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Partners with biostatistics, medical writers, and external consultants to understand and present the results ofclinical development programs.
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Partners with internal decision makers to evaluate critical decision points.
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Acts as a signatory for the medical monitoring team.
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Contributes to corporate initiatives by participating in continuous process improvement to meet companyobjectives as well as evaluates in-licensing opportunities and/or additional life cycle management opportunities.
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Participates in NDA development, submission and defense.
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Lectures at national and international meetings, scientific advisory board meetings, and data safety monitoring boards.
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Mentors junior team members.
Knowledge, Skills, Competencies, Education, and Experience
Required:
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A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. Board certification in Psychiatry and Neurology is highly desired. Minimum of five years of clinical research experience (post Academia).
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Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
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An advanced understanding of clinical medicine and science.
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Advanced understanding of drug development principles and clinical trial implementation and management.
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Complete understanding of the global regulatory requirements.
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Working knowledge of marketing and commercialization.
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Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
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Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,
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Demonstrated experience in leading a successful regulatory filing.
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Ability to work across different therapeutic areas and different stages of clinical development.
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Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).
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Strong communication and presentation skills.
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Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
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Knows how/when to apply organizational policy or procedures to a variety of situations.
Physical Demands and Work Environment
Travel (approximately 30 % )
See document Physical Demands and Work Environment for further requirements.
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 $245,454.00 - Maximum $381,110.00, 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.