9 дней назад
Manager, REMS Operations (Pharmaceutical)
128 000 - 192 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager, REMS Operations (Pharmaceutical): Managing day-to-day operations and governance for U.S. FDA-mandated REMS programs with an accent on regulatory compliance, cross-functional coordination, and operational risk management. Focus on executing program workstreams, developing and approving REMS materials, maintaining inspection-ready documentation, and mitigating risks and dependencies.
Location: Remote/Home-Based for US-based candidates, associated with Palo Alto, California or Philadelphia, Pennsylvania.
Base salary: $128,000–$192,000 annually, plus potential bonus, equity, and benefits.
Company
is a global biopharmaceutical company developing medicines for serious diseases, with a portfolio spanning sleep disorders, epilepsy, oncology, and neuroscience.
What you will do
- Manage day-to-day operations of U.S. FDA-mandated REMS programs and ensure regulatory and internal governance compliance.
- Provide strategic oversight of REMS initiatives and coordinate governance and operational workstreams.
- Develop agendas, facilitate meetings, manage timelines, document decisions, and follow up on action items with cross-functional stakeholders.
- Monitor program health, identify risks, dependencies, resource constraints, and operational issues, and implement mitigation strategies.
- Support the development, review, communication, modification, and approval of REMS materials.
- Partner with cross-functional teams and external vendors while maintaining records for inspections, audits, and governance activities.
Requirements
- 4–6 years of experience in the pharmaceutical industry.
- At least 2 years of pharmaceutical project and/or program management experience.
- Bachelor’s degree or equivalent in a relevant field.
- Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
- Excellent oral and written communication skills, strong organization, attention to detail, and the ability to work independently in a remote environment.
Nice to have
- Experience with REMS programs.
Culture & Benefits
- Remote/home-based work environment.
- Medical, dental, and vision insurance.
- 401(k) retirement savings plan.
- Flexible paid vacation.
- Potential annual cash bonus or incentive compensation and discretionary equity grants.
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