Manager, Medical Material Operations and Oversight Lead

Summary

Join Biogen as the Manager, Medical Material Operations and Oversight Lead, playing a crucial role in the US Medical team. You will be fully accountable for the successful execution and optimization of US Medical Material Review processes. A significant portion of your time will be dedicated to supporting the US neuropsychiatry therapeutic area as a Grants Coordinator. This role blends process leadership with contributions to medical and disease education through strategic grants coordination. You will report to the Director, Medical Excellence and Operations and collaborate with cross-functional teams. The position requires a Bachelor's degree (advanced degree preferred) and at least 3 years of relevant experience. Biogen offers a competitive salary and a comprehensive benefits package.

Requirements

• 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

Responsibilities

• 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
• 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
• 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
• 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
• 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
• 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

Preferred Qualifications

• 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.)
• Working with, maintaining, and /or creating Standard Operating Procedures (SOPs) and guidance documentation with experience in training for such documents strongly preferred

Benefits

• Medical, dental, life, long and short-term disability insurances
• Vacation
• End-of-year shutdown
• 401K participation and matching contributions
• Biogen’s LTI grants and other incentive programs