2 дня назад
PharmD Program Associate - Regulatory Labeling & Advertising/Promotion (Biotech)
98 100 - 160 100$
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Описание вакансии
Текст:
TL;DR
PharmD Program Associate - Regulatory Labeling & Advertising/Promotion (Biotech): Developing labeling content and strategies while supporting product-lifecycle labeling, promotional communications, FDA regulatory compliance, and OPDP interactions with an accent on interpreting regulations, clinical data, and safety information. Focus on drafting regulatory documents, assessing promotional and product risks, supporting regulatory submissions, and coordinating labeling reviews and approvals.
Location: Onsite in Tarrytown, New York, United States; travel up to 15%.
Salary: $98,100–$160,100 annually.
Company
is a biotechnology company developing medicines through global clinical development and regulatory programs.
What you will do
- Develop labeling content and labeling strategies by interpreting applicable regulations and guidelines.
- Support the labeling process throughout the product lifecycle, including Labeling Working Group reviews and management approvals.
- Evaluate promotional communications against FDA requirements to help ensure they are truthful and not misleading.
- Advise cross-functional teams on regulatory risks and support interactions with the FDA Office of Prescription Drug Promotion.
- Draft documents for clinical sites and regulatory submissions, and analyze clinical and safety data.
- Manage third-party vendors, maintain key-result timelines, and develop regulatory strategies for clinical development programs.
Requirements
- PharmD from an accredited ACPE College of Pharmacy program; PhD graduates in a life-science-related field may also be considered.
- Completion of the PharmD and/or PhD degree by Summer 2027.
- Familiarity with evaluating clinical trials, scientific literature, and clinical data.
- Eligibility to work permanently in the United States.
- Ability to work onsite in Tarrytown, New York and travel up to 15%.
Nice to have
- Prior internship or rotational experience in the pharmaceutical or biotechnology industry.
- Interest in clinical sciences, global clinical operations, regulatory affairs, or safety sciences.
Culture & Benefits
- Two-year, 24-month rotational development program with interdisciplinary training and mentorship from professionals.
- Exposure to multiple global development functions and an optional elective rotation.
- Opportunities to travel to clinical sites and meetings with health authorities.
- Benefits may include incentive plans, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
- Inclusive workplace with reasonable accommodation available during recruitment where required.
Hiring process
- Submit a resume and cover letter identifying the preferred program track; rank multiple tracks if applicable.
- Applications are accepted from August 24 through September 11, 2026.
- The recruitment process may include background checks to verify identity, work authorization, and educational qualifications.
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