Manager, Risk Management (REMS) Consultant
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Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Manager, Risk Management (REMS) Consultant for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
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. |
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Education/Experience:
· Experience managing third-party vendors, contracts, budgets, service levels, and performance remediation in a regulated environment Knowledge, Skills and Abilities:
· 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
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.
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