Manager, Expanded Access Programs
- Cambridge, MA
- Department: Medical Affairs
- Region: US
The Manager of Expanded Access Programs will be accountable for the successful delivery of daily program activities, by ensuring key program milestones are met, program updates are communicated in a meaningful and useful way to key stakeholders across the organization. The role will contribute to the success of the team by ensuring the team operationally executes programs and processes in line with the highest quality and compliance standards.
Additional Responsibilties Include:
- Develop and manage EAP project plan with timelines, team lists, and program budget trackers
- Manage Compassionate Use requests globally and associated expanded access mailbox ensuring appropriate triage and approvals are routed and documented per SOPs
- Responsible for the oversight and review of data captured by vendor for the program and trouble shooting at the affiliate level
- Provide metrics, invoice and financial tracking and reporting on EAP status
- Convey meaningful insights via effective display of data analysis outcomes to internal stakeholders and appropriate content publishing on EAP sites
- Manage daily activities of selected vendor of EAP and ensure, for example, Master Services Agreement (MSA), Statement of Work (SOW) and other relevant documentation are completed, successfully executed, and updated as needed
- Provide operational support to affiliate staff during the planning, launch and maintenance of EAPs in each country
- Partner with appropriate Medical functional contacts to develop training materials, and provide training to appropriate team members and stakeholders on program objectives, timelines, etc.
- Liaise with Biogen affiliate and distributor points of contact to ensure affiliate and distributor needs are fully represented and integrated successfully into EAP programs
- Participate and present in regular team meetings with both Biogen and selected vendors to track progress and outcomes, as appropriate.
- Build and maintain the EAP team data repository system and sharepoint folders. Responsible for compiling meeting minutes at all EAP team led meetings
- Requires a Bachelor’s degree in a science-related field and 5-7 years related professional experience as an early/expanded access and/or clinical trials manager. PMP or equivalent certification is a plus. Previous work experience in a CRO is a plus
- Proven experience in coordinating expanded access programs and/or clinical trials
- Experience with vendor management and program management
- Understanding of guidelines and other applicable local and international expanded access regulations
- Experience in global organization strongly preferred
- Experience working within cross-functional team
- Understanding of guidelines and other applicable local and international expanded access regulation
- Experience with vendor management
- Strong communication skills
- Experience developing and managing budgets and contracts
- Expert computer and internet skills including knowledge of Tableau and MS-Office products such as Project, Excel, Word and PowerPoint Expert.
- Ability to develop, enhance and execute on processes and procedures; regularly contribute to development of new or enhancement of existing business process methodologies and tools.
- Demonstrated ability to navigate in complex environments
- Great Project Management skills
- Proficiency in Microsoft Office and presentation preparation
- Manages and is accountable for professional employees and/or supervisors;
- Works independently, receives minimal guidance; may lead projects or may have accountability for on-going activities or objectives
- Provides technical guidance to employees, colleagues and/or customers
- Solves complex problems; decisions and problem solving are guided by policies, procedures and department plan
- Requires in-depth conceptual and practical knowledge in own job discipline and basic knowledge of related job disciplines
- Applies understanding of the business and how own area integrates with others to achieve departmental objectives
- Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market
- Adapts department plans and priorities to meet short-term service and/or operational objectives
- Acts as a resource for colleagues with less experience; may lead small projects with manageable risks and resource requirements
- Guides and influences others either internally or externally to adopt a different point of view
- Explains difficult or sensitive information; works to build consensus
Expanded Access Programs allow for patients with high unmet medical needs to access therapies prior to marketing authorization and reimbursement in their country. The Manager, EAP will liaise with representatives from key functions in Biogen (e.g., Global, Regional & Local Medical teams, Safety, Regulatory, Asset, Legal & Compliance, Value & Access, Finance, PO&T, Global, Regional and Local Commercial, etc) and manage external vendors to support the program management of Biogen’s EAPs. This role will be based in Cambridge, MA.