Your mission

Associate Director, Labeling and Promotional Materials

At Pierre Fabre Pharmaceuticals Inc. our mission is to deliver breakthrough therapies in oncology and rare diseases to patient populations with high unmet needs and limited treatment options. Our belief is that every time we care for a single person, we make the whole world better.  We are the US pharmaceutical subsidiary of Pierre Fabre Laboratories Worldwide, a foundation-owned company with 7 decades of impact. Pierre Fabre Laboratories is a truly global healthcare company, established in 43 countries, with products distributed in 119 territories across the globe. Pierre Fabre's foundation ownership enhances our ability to focus on creating long-term value for patients.  

Building on the legacy of Pierre Fabre Laboratories, innovation is our life blood and patient experience drives everything we do. We aspire to design and develop therapeutic solutions inspired by patients and healthcare professionals; draw on science and nature as perpetual sources of inspiration; develop long-term partnerships with researchers and innovators worldwide; and place pharmaceutical ethics and climate transition at the heart of our action. 

Pierre Fabre Pharmaceuticals is headquartered in Parsippany, NJ alongside Pierre Fabre USA Inc., a Pierre Fabre Laboratories subsidiary focused on dermatology and cosmetics. 

SUMMARY: 

Pierre Fabre is a large private French multinational pharmaceutical and cosmetics company building a new US oncology division. We are looking for creative, highly motivated individuals to help prepare for the successful launch of potentially the first allogeneic T-cell immunotherapy approved in the US (“Therapy”).  Patients with a history of bone marrow or solid organ transplant can suffer from this rare, often deadly lymphoma, which currently has no approved FDA therapies. Pierre Fabre Pharmaceuticals in the US currently markets HEMANGEOL® (propranolol hydrochloride) oral solution indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy.

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.

ESSENTIAL FUNCTIONS:

• 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.

REQUIRED EDUCATION AND EXPERIENCE:

• 8+ 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 c