9 дней назад
Senior Manager, REMS and Specialty Pharmacy Operations (Biotechnology)
160 000 - 190 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, REMS and Specialty Pharmacy Operations (Biotechnology): Supporting the implementation, execution, and optimization of REMS and specialty pharmacy operations for COMP360 in the United States with an accent on compliance, vendor coordination, and patient-centered workflows. Focus on monitoring program performance, supporting launch readiness, and solving operational issues across treatment sites, specialty pharmacies, and cross-functional partners.
Location: Hybrid in the Jersey City office or remote from the East Coast, United States. Applicants must have employment rights in the country to which they are applying.
Base salary: $160,000–$190,000 per year, plus discretionary bonus and equity.
Company
is a biotechnology company developing COMP360 psilocybin treatments for treatment-resistant depression and post-traumatic stress disorder.
What you will do
- Support implementation and ongoing execution of REMS workflows, including site certification, training, patient enrollment, treatment documentation, monitoring, and reporting.
- Manage specialty pharmacy workflows, distribution processes, partner onboarding, training, and operational readiness.
- Monitor program metrics, service levels, deviations, exceptions, risks, and compliance indicators.
- Coordinate day-to-day operations with REMS administrators, vendors, specialty pharmacies, and healthcare partners.
- Support launch readiness through testing, simulations, process validation, training deployment, and readiness assessments.
- Develop operational reports and dashboards, identify improvement opportunities, and track corrective or preventive actions.
Requirements
- 5–8 years of experience in pharmaceutical, biotechnology, specialty pharmacy, healthcare services, patient support, market access, or a related healthcare industry.
- At least 2 years of experience supporting REMS programs, specialty pharmacy operations, patient services, access operations, trade and distribution operations, or other regulated healthcare programs.
- Experience managing operational projects, coordinating cross-functional stakeholders, and working with external vendors or healthcare partners.
- Working knowledge of FDA REMS programs, specialty pharmacy, patient access, and limited distribution workflows.
- Strong project management, analytical, problem-solving, communication, and prioritization skills.
- Employment visa sponsorship is not available; applicants must already have employment rights in the country of application.
Nice to have
- Advanced degree such as an MBA, MPH, PharmD, MS, or equivalent.
- Experience supporting product launch, launch readiness, or commercialization activities.
- Experience developing SOPs, training materials, operational workflows, and process documentation.
- Knowledge of pharmaceutical compliance requirements and healthcare operational processes.
Culture & Benefits
- Flexible hybrid or remote work arrangement within the stated United States location.
- Generous time off and parental and reproductive support.
- Health, medical, mental health, wellbeing, and financial health benefits.
- Permanent hires receive base salary, discretionary bonus, equity, and comprehensive benefits.
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