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Manager, Promotion Compliance (PC Reviewer)
Company: Otsuka Pharmaceuticals
Location: Princeton, NJ
Employment Type: Full Time
Date Posted: 05/27/2022
Expire Date: 07/27/2022
Job Categories: Biotechnology and Pharmaceutical
Job Description
Manager, Promotion Compliance (PC Reviewer)
Role/Position Summary

Provides promotional review of marketing materials according to FDA regulations under supervision. Performs submission of marketing promotional materials to OPDP.

Key Responsibilities
Represents Promotion Compliance (PC) at Promotional Review Committee (PRC) meetings.
Provides critical regulatory review, and evaluates whether advertising, sales training materials, drug labels and labeling comply with FDA regulations and guidelines as well as company policies and procedures. Approves promotional materials for use as part of the PRC
Prepares promotional materials submissions to OPDP in accordance with regulatory requirements.
Assists in the analysis and interpretation of newly issued regulatory requirements pertaining to promotional labeling, as well as FDA Guidance Documents and Advisory Comments for advertising and promotional materials.
Provides training to OAPI/OPDC employees on regulations for promotion compliance as appropriate.


Knowledge/ Experience and Skills:

Knowledge of the drug development and post-approval processes
Excellent communication and interpersonal skills
Ability to work with multifunctional teams
Ability to communicate scientific/technical data and regulatory requirements with other departments, outside partners and FDA personnel
Ability to communicate scientific/technical data and regulatory requirements with other departments, outside partners and FDA personnel

Able to work across multifunctional groups
Strong written and oral communication skills
Demonstrated managerial skills
Strong computer skills including experience with MS Office: Word, Excel, PowerPoint, and Outlook, Teams, Adobe Acrobat, and Veeva PromoMats

Educational Qualifications
Bachelor's Degree (BA/BS) or higher with demonstrated proficiency of medical terminology.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.


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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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