Job Description
About This Role
As the Manager, Medical Material Operations and Oversight Lead, you will be a pivotal member of the US Medical team, taking full accountability for the successful execution and optimization of the US Medical (USM) Material Review processes and activities. In addition to your primary focus on leading material review processes, you will dedicate a portion of your time to supporting the US neuropsychiatry therapeutic area as a Grants Coordinator. This dual-focus role combines process leadership with the opportunity to contribute to advancing medical and disease education through strategic grants coordination. You will report directly to the Director, Medical Excellence and Operations and collaborate with cross-functional teams to achieve operational excellence and strategic impact.
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What You’ll Do
- Material Process Leadership: Act as a strategic partner to the Head of Science & Value Communication and USM Material Owners across TAs to lead and optimize the Medical Review Process. Drive a culture of agility, continuous improvement, and collaboration across stakeholders.
- Material Planning & Forecasting: Manage the planning and forecasting of US Medical materials using the Material Tracker. Facilitate quarterly planning meetings and ensure alignment with Medical Material Owners, Regulatory, and Legal teams for priority and capacity assessments.
- Material Review Submission: Foster a right-first-time culture for material submissions in the Veeva InSCite system. Review materials for dissemination-readiness and ensure appropriate routing to reviewers.
- Review Process Coordination: Facilitate review meetings for Medical Materials, including Concept Reviews for new initiatives. Collaborate with stakeholders to resolve comments and escalate issues as needed to achieve final approvals.
- Training and Communication Management: Manage the US Material Review SharePoint site and provide resources and training to stakeholders. Support broader US or North America medical needs through cross-training and project initiatives in areas like field systems, vendor management, and project management.
- Grants Coordination (Neuropsychiatry Support):
Support the US neuropsychiatry therapeutic area by assisting with grants-related activities, including due diligence, request reviews, decision communications, and payment tracking. Manage internal and external communications related to grants, maintain accurate records, and ensure compliance with governance requirements. Collaborate with cross-functional stakeholders to update grants-related resources and support strategic objectives.
Who You Are
You are a professional with a talent for paying attention to details and enjoy supporting medical operations activities. You are highly adaptable and action oriented. You will also need to be a strong collaborator, have a strategic mindset and be self-motivated.
Qualifications
Required Skills
- Bachelor's degree required (advanced degree preferred)
- Minimum of 3 years of experience in medical affairs, operations, vendor or contract management, research operations, budget management, or related fields.
- A track record of exhibiting self-motivation, agility and a continuous improvement mindset are critical to this role’s success.
- Demonstrated experience in leading and overseeing the execution of critical operational systems (preferred experience with strategy and design of those systems)
- At least some project / program management experience and must have strong organizational, timeline management, and leadership skills
- Working with, maintaining, and /or creating Standard Operating Procedures (SOPs) and guidance documentation with experience in training for such documents strongly preferred
Preferred Skills
- Advanced Scientific or Clinical degree; doctoral (MD, PhD, PharmD) level preferred. (Having an advanced degree may reduce the required years of industry experience)
- Previous medical affairs experience strongly preferred, especially with field systems (e.g. Veeva), as an MSL, and/ or in medical operations
- Excellent command of computer skills (Excel, Outlook, Word, Power Point, Smartsheet etc.)
Additional Information
The base compensation range for this role is $109,000 - $158,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.
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.