About This Role As part of the Global Medical Capabilities Governance, Risk, and Control team, the Associate Director, Medical Research Governance is responsible for governance of post-market medical research. Proposals include company-sponsored and investigator-sponsored studies, and the research may be on Biogen’s marketed products or in our disease areas. This individual will be responsible for the research review processes and administer the Medical Research Review Committee. The job involves interaction and partnership with Global, Regional, and Local stakeholders in all of Biogen’s therapeutic areas.What You’ll Do Administer the Medical Research Review Committee (MRRC) to facilitate the review of proposals against defined criteria, including managing review deadlines and inform appropriate stakeholders of the resultsConduct budget review and fair market value analysis of investigator budgets and review submissions, protocols, reports, and amendments to ensure they are compliant and to provide operational feedbackEnsure appropriate review of proposal submissions, study protocols, study amendments, and study reports to ensure they meet requirementsDevelop and maintain the relevant standard operating procedures for research review and investigator sponsored research, including collaboration with cross-functional partners to develop and/or improve processes and proceduresPresent study results summaries to the product Safety Surveillance Teams and document outcomesManage and report on progress and performance metrics using the Medical Affairs Research SystemEducate stakeholders about the MRRC process, develop and deliver relevant training, and assist internal team members and external investigators with proposal submissionsPartner with quality functions to support audits, inspections, and CAPA management as needed
