Manager, Risk Management (REMS) Consultant

Position Summary

The Manager, Risk Management supports the development, implementation, operational execution, monitoring, and assessment of Risk Evaluation and Mitigation Strategies (REMS) and U.S. risk management strategies under the oversight of the Client.

Key Responsibilities

REMS Program Strategy and Operations

Support the development, implementation, daily operations, monitoring, and modification of assigned REMS and U.S. risk management strategies

Propose and assist with the development and implementation of REMS modifications

Support operational readiness for launches, REMS modifications, and program transitions across business, quality, PV, call center, portal, and IT functions

Provide regular REMS status reports, proposals, and materials for review and approval

Support REMS Assessment Report planning, data collection, review, approval, and submission

Triage REMS operational inquiries and ensure timely response, documentation, and escalation

Collaborate across therapeutic areas to support REMS and risk management activities

Governance and Stakeholder Management

Coordinate and support REMS Core Team governance, including meeting materials, agenda, minutes, decisions, actions, risks, and escalations per Clients directive

Partner cross-functionally and provide concise program updates and decision materials to stakeholders and leadership

Train internal and external stakeholders on REMS requirements and processes

Compliance, Quality, and Inspection Readiness

Maintain controlled workflows, records, and inspection-ready documentation

Support audits and inspections; track findings, manage corrective and preventative actions (CAPAs), commitments, and remediation through closure, as required

Assist in the development, maintenance, and updating of REMS standard operating procedures (SOPs)

Coordinate development of responses to FDA information requests and related regulatory correspondence

Contribute to electronic document review, approval, and archiving systems, including development of REMS specific workflows

Assist with monitoring program and vendor compliance metrics for trends and escalate as warranted

Vendor, Contract, and Financial Oversight

Support client regarding vendor oversight of deliverables, service levels, quality events, effectiveness surveys, audits, remediation, and performance reviews

Support budget forecasts and contract alignment for current and future scope of work; and purchase order- invoice reconciliation as needed

Metrics, Reporting, and Risk Management

Monitor for and identify program risks, dependencies, resource constraints, and operational concerns/issues, such as (e.g., potential launch delays, system defects, resource gaps, or unresolved cross-functional dependencies); propose and support mitigation planning and escalation.

Education/Experience:

Bachelor’s degree (life sciences preferred)
Minimum of 3 years of relevant experience, with at least 1 year in REMS, Regulatory Affairs, Pharmacovigilance, Medical Affairs, Medical Writing, or a related function
Equivalent combination of advanced degree and reduced experience may be considered
Knowledge of FDA regulatory requirements across the prescription drug development lifecycle, including post‑marketing activities and U.S. submissions
Experience with risk management program operations, including call center operations, database management, and effectiveness assessments
Excellent written and verbal communication skills (English required)
· Experience managing third-party vendors, contracts, budgets, service levels, and performance remediation in a regulated environment

Knowledge, Skills and Abilities:

Strong cross‑functional collaboration and stakeholder management skills
Ability to influence within function, cross‑functionally, and globally
Excellent organizational, analytical, and problem‑solving abilities
High attention to detail with strong documentation practices
Ability to manage multiple priorities in a regulated environment
· Proficiency with data reconciliation, and electronic document regulatory information management systems

Preferred Qualifications

· Advanced degree (MA, MBA, MHA, PharmD, or similar)

· Experience with clinical trial operations, pharmacovigilance operations, and/or NDA/BLA submissions

· Experience coordinating interactions with regulatory agencies, including scientific, regulatory, and safety meetings

· Experience with product launch readiness, or major REMS program transitions

· Project management certification or demonstrated pharmaceutical project/program management experience

Additional Requirements

Ability to travel domestically up to 10%