Manager, Risk Management (REMS) Consultant

Position Summary

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

Compliance, Quality, and Inspection Readiness

Vendor, Contract, and Financial Oversight

Metrics, Reporting, and Risk Management

Education/Experience

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%
• The Application Process
• Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
• Who will you be working for?
• About ClinChoice
• ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
• Our Company Ethos
• Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
• ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.