Director, Risk Management Lead
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Responsible for RM Lead activities for numerous and complex compounds. Take initiative/ assume lead role in across-compound RM activities. Serve as in-house expert on designated RM topics. May assume personnel management responsibilities.
Essential Functions required for the job. List both technical and managerial requirements if applicable.
. With oversight from Head of RM, responsible for all risk management activities for assigned compounds including and not limited to: signal management; responses to regulatory agency queries; preparation, review and finalization of safety documents (DSURs, PSURs, development RMPs, RMPs, etc); review and contribute to clinical documents (Investigator Brochures, protocols, clinical study reports, etc) focusing input on safety sections
2. Lead cross-function Safety Monitoring Team activities for assigned compounds
3. Represent Risk Management for assigned compounds on cross-functional teams, including Regeneron Safety Oversight Committee, Independent Data Monitoring Committees and other teams with members external to Regeneron
4. Proactively identify and develop plans/ strategies for non-compound specific risk management activities
5. Resource for medical review of assigned compounds
6. Actively participate in the development and maintenance of relevant SOPs and working practices
7. Actively participate in process improvement activities within PVRM
Ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required. Function as a subject matter expert internal and external to PVRM for assigned compounds. Ability to utilize PVRM safety database for purposes of medical case review and simple queries. Ability to effectively communicate (verbal and written) and defend safety findings and recommended risk management and minimization activities.
Clinical experience and 2+ years of industry experience in drug safety including significant experience with PSURs/ DSURs/ (d)RMPS; or in clinical development with demonstrated achievements in safety (ex. supporting an ISS; responsible for CSR content).
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
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Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.