обновлено 7 дней назад
VP/Sr. VP of Advertising & Promotional Review
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
VP/Sr. VP of Advertising & Promotional Review (FDA Regulatory Compliance): Leading promotional review and labeling services for pharmaceutical, biotech, medical device, and combination products with an accent on FDA compliance, OPDP submissions, and product communications across the product lifecycle. Focus on developing review processes, directing cross-functional expert teams, advising executive and regulatory stakeholders, and delivering complex client projects on time and within budget.
Location: United States. Remote work is supported; employees within a reasonably short commute of an office are encouraged to work on a hybrid basis with manager approval.
Company
provides regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology consulting services for biotech, medical device, and pharmaceutical organizations.
What you will do
- Lead regulatory, medical, and legal promotional review and labeling services for drugs, biologics, combination products, OTC products, and medical devices.
- Develop roadmaps, processes, and infrastructure supporting product communications and product development throughout the lifecycle.
- Advise clients on promotional tactics aligned with FDA requirements and provide strategic input for health authority interactions.
- Partner with C-suite executives, compliance officers, legal counsel, auditors, board committees, and regulatory, clinical, and medical affairs functions.
- Lead assigned client projects, coordinate subject matter experts, and ensure high-quality, on-time, and on-budget delivery.
Requirements
- Expert knowledge of FDA Office of Prescription Drug Promotion regulations and pharmaceutical advertising, promotion, labeling, and compliance guidelines.
- Deep understanding of advertising and promotion review and approval processes, including OPDP submissions and new product labeling development.
- 15+ years of progressive leadership experience in promotional review and labeling services within a regulated pharmaceutical or biotech company, consulting firm, CRO, or FDA.
- Master’s degree in life science or a related field required; a higher degree is preferred.
- Experience leading technical professionals and cross-functional teams, with strong analytical, strategic planning, communication, and collaboration skills.
Culture & Benefits
- Remote work is supported, with hybrid collaboration encouraged for employees located near an office.
- Inclusive workplace focused on diversity, equity, inclusion, innovation, collaboration, and entrepreneurship.
- Applications are personally reviewed by the recruitment team without AI screening tools.
- Applicants receive an outcome regarding their application.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
18 часов назад
Vice President, Operations (Bioprocessing)
240 000 - 345 000$
2 дня назад
Director, Pharmacy Coverage Reviews (Pharmacy)
2 дня назад
Associate Director/Director, Global Strategy Lead (Biotech)
193 629 - 254 137$
7 дней назад
Director, Business Services (Medicaid Operations)
6 дней назад
Sr. Director, Enterprise Business Partner, Commercial & Growth (MedTech)
196 100 - 294 200$
6 дней назад
Vice President Regional Leader (Healthcare Supply Chain)
187 800 - 348 300$