Head of Advertising, Labeling, and Promotion (ALP)
Responsibilities
- Oversee US promotional reviewers; ensure timely, collaborative review of promotional materials for marketed and pipeline assets.
- Provide strategic guidance on claims, fair balance, risk communication, and product differentiation during development and commercialization.
- Advise on regulatory risk, opportunity assessment, and decision-making for product communication.
- Monitor FDA regulations, advisory comments, and compliance initiatives; educate cross‑functional partners.
- Collaborate with Commercial, Medical Affairs, Legal, and Market Access to enable compliant product communications.
- Adapt policies and capabilities for digital, social media, omnichannel engagement, and AI‑enabled content generation.
- Lead labeling activities across the product lifecycle (target label profiles, indication expansions, core data sheets, safety updates).
- Partner with Global Regulatory Affairs on target labeling profiles and ensure development plans support labeling objectives.
- Develop internal policies, SOPs, and training for labeling, advertising, and promotion.
- Build, develop, and mentor a high‑performing team across labeling and advertising/promotion.
- Drive ownership/accountability, collaboration, and scientific rigor; ensure scalable processes for portfolio growth.
- Own budget and resource planning for the ALP function.
Required Skills/Qualifications
- Advanced degree preferred (PharmD, PhD, JD, or equivalent).
- 15+ years progressive regulatory experience in pharma/biotech.
- Leadership experience overseeing advertising and promotion review for marketed products.
- Hands‑on product labeling development experience.
- Experience supporting early‑stage pipeline programs through launch and post‑approval lifecycle.
- People leadership and matrixed team management experience.
Preferred Skills
- Expert command of FDA OPDP requirements, enforcement trends, guidance, and case law.
- Knowledge of global labeling frameworks (FDA PLR/CDS/SPL/USPI, EMA/SmPC, and regional variants).
- Claims substantiation, fair balance/risk communication, comparative and disease‑awareness advertising.
Benefits (as stated)
- Medical, dental, vision, life insurance; fitness/wellness reimbursement; disability insurance.
- Paid vacation and shutdown; holidays; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan.
- Tuition reimbursement up to $10,000/year; employee resource groups participation.