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9 дней назад

Manager, REMS Operations (Pharmaceutical)

128 000 - 192 000$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
US/Ireland
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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

hirify.global 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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