Global Risk Management and REMS Strategy Lead
4 weeks ago
We are seeking an experienced Executive Director to lead our Global Risk Management and REMS team. As a key member of our leadership team, you will be responsible for developing and implementing our GRMR strategy, driving business growth, and ensuring the delivery of high-quality services to our clients.
Key Responsibilities
- Develop and implement GRMR strategy, including submissions, assessments, and new GRM solutions
- Lead a high-performing team, providing guidance, coaching, and development opportunities
- Collaborate with cross-functional teams to advance GRMR awareness and represent GRMR solutions in broader corporate initiatives
- Build and maintain relationships with clients, stakeholders, and industry partners
- Stay up-to-date with industry trends, regulations, and best practices, and apply this knowledge to drive business growth and innovation
Requirements
- Advanced degree in a science or healthcare field
- 15+ years of experience in the pharmaceutical, life science, or consulting industries, with at least 5 years of senior leadership experience
- Significant experience working with REMS programs, strong knowledge of REMS legislative and FDA guidance environment, and GvP quality systems
- Direct experience interfacing with FDA Division of Risk Management and FDA inspectors
- Strong leadership, communication, and interpersonal skills
What We Offer
- Competitive compensation package
- Health benefits, including medical, dental, and vision
- Company match 401(k)
- Flexible paid time off (PTO) and sick time
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