REMS Program Lead - Compliance & Operations

RXinsider LTD.; Bridgewater (MA); On-site; USD 140,000 - 155,000; Full time

Job summary

Amneal is seeking an REMS Manager to lead operational management, compliance, and oversight of REMS programs within Global Patient Safety. You will ensure programs are implemented and maintained in line with FDA requirements and company standards, reporting to the Senior Director of GPS.

The role involves coordinating multi-stakeholder teams, overseeing shared and single-sponsor REMS activities, and delivering data-driven insights through dashboards and reports.

Qualifications

• 3+ years in REMS and pharmacovigilance, with at least 2 years in Pharmaceutical Industry.
• Bachelor's Degree in Biological Science required; Master's preferred.
• Strong knowledge of FDA regulations and pharmacovigilance practices.

Responsibilities

• Oversee REMS program operations and day-to-day REMS activities across the organization.
• Support development and implementation of REMS programs for products in development.
• Maintain oversight of REMS operational readiness for new product launches.
• Represent the company in shared REMS programs and coordinate with sponsors and third-party administrators.
• Lead operational oversight of single-sponsor REMS programs and monitor compliance obligations.
• Own REMS metrics, KPI reporting, dashboards, and executive updates.
• Support FDA inspections and internal audits; track commitments and CAPAs.
• Manage REMS vendor relationships and conduct periodic governance reviews.
• Prepare executive-level reporting and communicate REMS program changes and risks to leadership.

Skills

Leadership

Communication

Pharmacovigilance

Data analysis

Stakeholder management

Education

Bachelor’s in Biological Science

Master in Biological Science

Job description

Amneal is seeking an REMS Manager to lead operational management, compliance, and oversight of REMS programs within Global Patient Safety. You will ensure programs are implemented and maintained in line with FDA requirements and company standards, reporting to the Senior Director of GPS.

The role involves coordinating multi-stakeholder teams, overseeing shared and single-sponsor REMS activities, and delivering data-driven insights through dashboards and reports.