Manager, REMS Operations

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Assist in the daily management of U.S. FDA-required REMS programs, ensuring adherence to regulatory standards and internal governance policies.

• Offer strategic direction for REMS initiatives and ensure that program implementation aligns with organizational goals.

• Oversee REMS governance and operational workflows, which include developing agendas, facilitating meetings, managing timelines, documenting meeting minutes, and following up on action items.

• Assess the health of the REMS program by identifying risks, dependencies, resource limitations, and operational challenges.

• Execute mitigation strategies to ensure business continuity.

• Assist in the creation, staging, review, communication, and approval of REMS materials.

• Collaborate with cross-functional teams and external vendors to fulfill REMS program requirements.

• Keep accurate documentation and records for regulatory inspections, audits, and internal governance processes.

⛳️ Requirements

• 4–6 years of experience in the pharmaceutical sector.

• At least 2 years of experience in pharmaceutical project and/or program management.

• Experience with REMS is preferred.

• Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.

• Exceptional oral and written communication abilities.

• Highly organized with a strong focus on detail.

• Capable of working independently and maintaining discipline in a remote work setting.

• A Bachelor's degree or an equivalent qualification in a relevant field is required.

🏝️ Benefits

• Discretionary annual cash bonus or incentive compensation.

• Discretionary equity grants.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401k retirement savings plan.

• Flexible paid vacation.