6 Pharmaceutical Services jobs in Anderson Island

Position Summary

Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.

J ob Responsibilities

• Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).

• Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products.

• Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed.

• Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.

• Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines.

• Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.

• Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities.

• Serves as the sponsor point of contact to the health authority.

• Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues.

• Effectively manages and directs internal support staff and external consultants for assigned projects.

• Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions.

• Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output.

• Assess and develop innovative ideas to move GRA department to address current and future challenges.

K nowledge, Skills, and Competencies

K nowledge

• Experience working in the pharmaceutical and/or healthcare industry.

• Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA).

• RAC certification a plus.

Skills

• Strong oral and written communication skills.

• Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc.

• Able to successfully interpret and apply regulatory intelligence to work output.

• Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed.

• Able to establish close communications and working relationship with cross functional teams to meet business objectives.

Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow.

• Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS).

Competencies

See OPDC Competencies Chart (Level X)

P hysical Demands and Work Environment

Travel (approximately 20%)

See document Physical Demands and Work environment for further requirements.

Education and Related Experience

Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable.

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 $146,955.00 - Maximum $210,100.00, 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.

**Position Summary**
Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.
**J** **ob Responsibilities**
- Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).
- Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products.
- Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed.
- Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.
- Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines.
- Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.
- Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities.
- Serves as the sponsor point of contact to the health authority.
- Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues.
- Effectively manages and directs internal support staff and external consultants for assigned projects.
- Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions.
- Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output.
- Assess and develop innovative ideas to move GRA department to address current and future challenges.
**K** **nowledge, Skills, and Competencies**
**K** **nowledge**
- Experience working in the pharmaceutical and/or healthcare industry.
- Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA).
- RAC certification a plus.
**Skills**
- Strong oral and written communication skills.
- Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc.
- Able to successfully interpret and apply regulatory intelligence to work output.
- Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed.
- Able to establish close communications and working relationship with cross functional teams to meet business objectives.
Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow.
- Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS).
**Competencies**
See OPDC Competencies Chart (Level X)
**P** **hysical Demands and Work Environment**
Travel (approximately 20%)
See document Physical Demands and Work environment for further requirements.
**Education and Related Experience**
Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable.
**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 $146,955.00 - Maximum $210,100.00, 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.

**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**
+ Remote position, **west coast hours mandatory**
+ Coordinate the complaint handling process to include processing of reportable events
+ Provide information as requested for the filing of FDA recalls
+ Coordinate FMI process, including monitoring and reporting status and completion
+ Process electronic submissions (e.g. 3500A, 2579, Product Reports, Annual Reports)
+ Coordinate state registrations, including monitoring regulations and preparing and submitting documentation to each state as required
+ As requested, write/review CMSU policies, procedures and guidance documents incorporating regulatory requirements/actions
+ Assist in maintaining proper preparedness for State or Federal (FDA) authorities
+ Represent interests of RA in cross functional teams as needed
#LI-Remote
#LI-NA1
**QUALIFICATIONS**
+ Excellent interpersonal, communication, and organizational skills
+ Ability to develop and maintain effective working relationships internally and externally
+ Good PC skills, including MS Word, Excel, Oracle, Sales Force, etc.
+ 2 Years Regulatory Affairs experience in medical device industry required
+ Minimum Education Level: 2 Year / Associate's Degree
+ 4 Year/ Bachelor's Degree (STEM) preferred
+ 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._

**Description**
**Job Summary**
Responsible for participating, conducting, and managing clinical research studies. Acts as a liaison between the clinic and the outside sponsoring firm. Coordinates and manages patient participation and data management for assigned studies.
**Essential Functions**
+ Recruit patient population and assists the physician(s) to identify patients and determine eligibility.
+ Conducts Informed Consent sessions with interested research subjects in compliance with all applicable federal, state and local regulations as well as the standards of Good Clinical Practice and the policies and procedures mandated by the study sponsor.
+ Responsible for establishing and maintaining a record-keeping system for each study. Maintain permanent records on all research protocols and cooperate with the study sponsor. Collect data through all phases of the study & assures appropriate completion of all documentation.
+ Provide and communicate protocol information and support to patients, physicians, research staff and all associated sponsor personnel or ancillary study personnel participating in active protocols.
+ Communicates appropriately with the person served regardless of their age.
+ Performs other duties as assigned.
**Qualifications**
**Education**
+ Associate Degree Required: Nursing and
+ Bachelor's Degree Preferred: Nursing.
**Experience**
+ Minimum of 3 years Required: Nursing experience in field relevant to hiring department and
+ Preferred: Clinical research experience
**Credentials**
+ Required: Registered Nurse in state of practice and
+ Preferred: Oncology Certified Nurse and
+ Preferred: Association of Clinical Research Certified Professional and
+ May be required Upon Hire: Basic Life Support and
+ May be required: National Institute of Health Stroke Scale Certification
**Skills**
+ Excellent organizational skills (Required)
+ Strong communication skills, both verbal and written (Required)
+ Problem solving skills (Required)
+ The ability to work independently in a multi-task environment (Required)
+ Proficient computer skills including Microsoft Office applications (Required)
+ Self-starter (Required)
+ Familiarity with health record data base systems (Preferred)
**Working Conditions**
Lifting
+ Consistently operates computer and other office equipment.
+ Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.
+ Sedentary work.
Environmental Conditions
+ Predominantly operates in an office environment.
+ Some time spent on site in medical/hospital setting.
Mental/Visual
+ Ability to communicate and exchange accurate information.
+ The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.
PeaceHealth is seeking a RN Clinical Research for a Full Time, 1.00 FTE, Day position. The salary range for this job opening at PeaceHealth is $49.64 - $74.46. The hiring rate is dependent upon several factors, including but not limited to education, training, work experience, terms of any applicable collective bargaining agreement, seniority, etc.
PeaceHealth is committed to the overall wellbeing of our caregivers: physical, emotional, financial, social, and spiritual. We offer caregivers a competitive and comprehensive total rewards package. Some of the many benefits included in this package are full medical/dental/vision coverage; 403b retirement plan employer base and matching contributions; paid time off; employer-paid life and disability insurance with additional buyup coverage options; tuition and continuing education reimbursement; wellness benefits, and expanded EAP and mental health program.
See how PeaceHealth is committed to Inclusivity, Respect for Diversity and Cultural Humility ( .
For full consideration of your skills and abilities, please attach a current resume with your application. EEO Affirmative Action Employer/Vets/Disabled in accordance with applicable local, state or federal laws.
REQNUMBER: 114849

You Belong Here

At MultiCare, we strive to offer a true sense of belonging for all our employees. Across our health care network, you will find a dynamic range of meaningful careers, opportunities for growth, safe workplaces, and flexible schedules. We are connected by our mission - partnering and healing for a healthy future - and dedicated to the health and well-being of the communities we serve.

FTE: 1.0, Shift: Day, Schedule: Monday - Friday, potential for weekend work

Position Summary

The Clinical Research Coordinator I is responsible for the implementation of clinical studies, typically basic science, phase II, III, and IV trials, and IIR studies. This position requires interaction with a wide variety of internal and external groups to include nursing staff, management, physicians, patients, outside organizations, research groups and service groups such as laboratories, pharmacy and radiology.

Responsibilities

• Coordinates clinical research pertaining to clinical research in human subjects.
• Follows guidelines for identifying subject populations, complete forms, questionnaires, and clinic procedures for collecting and summarizing observations and data.
• Prepares for and participates in study monitor visits.
• May perform venous blood draws within the practice scope of a Medical Assistant Phlebotomy license.
• Coordinates and oversees processing, inventory and shipping of study specimens.
• Documents and maintains accurate records of study visits and procedures to include financial accrual, source document and eCRF completion in compliance with applicable regulations and department procedures.
• Completes and submits sponsor queries within 3 5 business days from receipt.

Requirements

• High school education required
• Bachelors' degree in science, healthcare or other related fields preferred
• Minimum 1-year prior experience as a research assistant or coordinator within a healthcare setting
• CPR required
• Valid Washington State driver's license

Our Values

As a MultiCare employee, we'll rely on you to reflect our core values of Respect, Integrity, Stewardship, Excellence, Collaboration and Kindness. Our values serve as our guiding principles and impact every aspect of our organization, including how we provide patient care and what we expect from each other.

Why MultiCare?

• Belonging: We work to create a true sense of belonging for all our employees
• Mission-driven: We are dedicated to our mission of partnering for healing and a healthy future and the patients and communities we serve
• Market leadership: Washington state's largest community-based, locally governed health system
• Employee-centric: Named Forbes "America's Best Employers by State" for several years running
• Technology: "Most Wired" health care system 15 years in a row
• Leading research: MultiCare Institute for Research & Innovation, 40 years of ground-breaking, clinical and health services research in our communities
• Lifestyle: Live and work in the Pacific Northwest - offering breathtaking water, mountains and forest at every turn

Pay and Benefit Expectations

We provide a comprehensive benefits package, including competitive salary, medical, dental and retirement benefits and paid time off. As required by various pay transparency laws, we share a competitive range of compensation for candidates hired into each position. The pay scale is $28.13 - $40.49 USD. However, pay is influenced by factors specific to applicants, including but not limited to: skill set, level of experience, and certification(s) and/or education. If this position is associated with a union contract, pay will be reflective of the appropriate step on the pay scale to which the applicant's years of experience align.