Job Description
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 results
- Conduct 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 feedback
- Ensure appropriate review of proposal submissions, study protocols, study amendments, and study reports to ensure they meet requirements
- Develop 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 procedures
- Present study results summaries to the product Safety Surveillance Teams and document outcomes
- Manage and report on progress and performance metrics using the Medical Affairs Research System
- Educate stakeholders about the MRRC process, develop and deliver relevant training, and assist internal team members and external investigators with proposal submissions
- Partner with quality functions to support audits, inspections, and CAPA management as needed
Qualifications
- Bachelor's Degree in a relevant life science or equivalent training / experience is required. Advanced degree preferred.
- At least five (5) years of experience in medical / clinical operations, ideally related to investigator sponsored research.
- Ability to operate effectively in a highly matrixed organization with diverse stakeholders, with strong interpersonal skills
- Highly organized, with attention to detail and good project management skills
- Ability to work independently and make and document key decisions
- Excellent communication and presentation skills
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
