2024-05-15
AppCast (https://www.appcast.io)
Other
/yr
full-time
employee
Cambridge
Massachusetts
02140
United States
Promotional & Advertising Project Manager
Cambridge, MA-Can be remote!
External Title: Promotional & Advertising Regulatory Affairs, Promotional Compliance - US Regulatory Affairs
6 Months extendable contract
Pay Range: $150-175/hr on w2
Fully Remote Position *Candidates must be able to work EST Hours If a local candidate has the ability to work onsite Must-Have: Minimum of 5 years of experience in a related role responsible for Promotional & Advertising Regulatory Affairs, Promotional Compliance Must have biologic/ drug Related Experience (device experience is not a match) Ability to work with cross-functional teams Pharma Experience required (can be direct or consultant related) Nice to Have: Experience with Veeva 5+ years of experience
Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials.
Work directly with Commercial teams from concept through review and approval, up to and including OPDP/APLB submission.
Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials
Work collaboratively with Compliance and Legal to ensure that materials approved by RC are used within the intended guidelines.
Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives.
Work collaboratively with medical and scientific personnel on the development and review of materials related to advertising and promotion.
Participate in training of sales and marketing personnel on promotional, labeling and advertising regulations.
Serve as FDA liaison for matters related to the advertising and promotion of assigned products
Minimum Education: Bachelor's Degree
Years of Experience: 6 plus years
