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Associate Director, Labeling and Promotional Materials
@PIERRE FABRE PHARMACEUTICAL INC (USA)
[Hiring] Associate Director, Labeling and Promotional Materials @PIERRE FABRE PHARMACEUTICAL INC (USA)
Mar 14, 2025 - PIERRE FABRE PHARMACEUTICAL INC (USA) is hiring a remote Associate Director, Labeling and Promotional Materials. 💸 Salary: unspecified. 📍Location: USA.
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Role Description
The Associate Director, Labeling and Promotional Materials will play a critical role in supporting the labeling creation, approval and maintenance and leading the advertising and promotional materials review process for the Pierre Fabre Pharmaceutical US product portfolio. This is an exciting opportunity to be part of an organization that is preparing to launch a new class of advanced therapeutics while making a meaningful impact in the lives of patients with a life-threatening disease.
- Leads the labeling, advertising, and promotional activities for the Pierre Fabre Pharmaceuticals portfolio.
- Collaborate with colleagues in Commercial, Medical Affairs, Legal and Compliance and other expertise areas in creation of promotional and disease awareness communications, field training materials, and materials and communications used in scientific exchange, for assigned product(s).
- Act as Pierre Fabre Pharmaceuticals (PFP) US liaison to the FDA’s Office of Prescription Drug Promotion (OPDP) for the PFP products, including preparing correspondence for advisory comment submissions, and conducting negotiations.
- Monitor new or revised legislation, regulations, guidance documents, industry standards, and enforcement actions related to promotional communications, disease awareness, scientific exchange, and human subject protection, and analyze and communicate their relevance.
- Work closely with Regulatory Operations in making timely submissions of promotional materials to FDA.
- Oversees and guides the preparation, review, approval, and maintenance of U.S. labeling for the Pierre Fabre Pharmaceuticals portfolio of products.
- Represents Regulatory Affairs US Labeling on Worldwide Regulatory Affairs Project Teams, cross-functional submission teams, and on joint labeling / safety meetings with R&D and partner companies.
- Oversees the activities related to artwork requests, archiving labeling documents, and updating label histories.
- Manages complex labeling negotiations with the US FDA.
- Trains other Worldwide Regulatory Affairs colleagues or cross-functional team members in various matters relating to US labeling.
- Acts as system owner for the Promomats system.
Qualifications
- 10+ years of biotech/pharma required with 6+ years’ experience in prescription drug labeling.
- Bachelor’s degree required, post graduate degree or RAPS US certification desirable.
- Extensive experience leading development of regulatory labeling or related strategies as well as Ad/Promo strategy and leadership.
- Extensive experience in NDA/BLA labeling and labeling negotiations.
- Extensive experience participating in cross-functional projects and teams.
- Rare diseases and/or oncology experience is highly desirable.
- Experience with biologics; cell or gene therapy experience is highly desirable.
- Veeva knowledge and experience is a plus.
- Scientific curiosity, creativity, and flexibility.
- Ability to thrive in a fast-paced startup environment with high expectations.
- Ability to appropriately access and handle business information in compliance with all applicable laws, regulations and / or Pierre Fabre policies.
- A passion for making a difference in the lives of patients.
Requirements
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Location: US, remote.
Benefits
- Join Pierre Fabre for competitive benefits including three medical plans, dental and vision coverage, voluntary benefits, a 401(k) plan, and more!
- Hybrid work policy.
- Generous PTO policy and company holidays.
- Paid parental leave.
- Discounts on our products.
- Learning and development opportunities.
- Access to mental health and wellness programs.
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
All others
All others
|
Salary
💸
unspecified
|
Remote
Location
USA
|
|
Job Type
full-time
|
Posted
Mar 14, 2025
|
️
| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
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