Head of Advertising, Labeling, and Promotion

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.

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