Regulatory Affairs Manager with Advertising/Promotion - King Of Prussia, PA


Ad
Complete Read and Understand + Instructor-led training for Copy Approval procedures and access to Planner for ad/promo review
Complete CIA training, as required for CAT member
Supervisor-led training for specific guidance and procedures related to Bexsero (e.g., submissions to APLB for 30-day hold) and Shingrix.
Provide general regulatory advice and guidance for ad/promo concepts, including DTC ads.
Interact with APLB reviewers to obtain advice on promotional concepts and strategies.
Review unbranded and branded ad/promo materials in Planner system, per current procedures.
Attend weekly Copy Approval Meetings (1 to 3) to discuss comments on ad/promo items and reach consensus on resolution.
Escalate unresolved issues within Regulatory line management, when necessary.

Preferred background/requirements:

BS/BA in scientific discipline
At least 5 years experience in US-facing RA supporting marketing products, including ad/promo review
Experience with advertising for vaccine products and working with APLB preferred

Travel:

Travel would be limited to connecting with the manager (in KoP area for the two years) to get setup on client systems and meet colleagues... View Full Description

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