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Job Details


Sr Project Manager, Global Access Mechanisms

Life, Physical, and Social Science



Full Time


Cambridge, Massachusetts, United States

Company Description Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. Job Description The Sr. Project Manager, Global Access Mechanisms (GAM), will have deep knowledge of global early access principles, regulatory requirements, and vendor oversight responsibilities. They must possess a strategic mindset and the role will be accountable for helping to successfully drive daily program activities, by ensuring the critical milestones are met, program updates are communicated in a meaningful and useful manner across the organization. This role will contribute to the success of the team by being able to work cross-functionally to ensure a high-level of operational execution is achieved in-line with compliance standards and company policies. What You’ll Do · Provide operational/strategic support to Project Leader, GAM and Head, GAM in the development of GAM access strategies · Design/leverage appropriate project management platform and dashboard for cross-functional reporting · Develop and Manage GAM project plans with timelines, accountable parties, and program budget trackers · Coordinate and facilitate key project team meeting and act as the lead of certain sub-teams · Ability to manage global compassionate use requests globally, including triaging the requests via the associated processes to ensure the appropriate approvals and endorsements are completed per SOPs · Provide metrics, invoice and financial tracking and reporting on GAM programs · Consolidate & review supply estimates in alignment with cross-functional colleagues to track drug forecast and estimate demand · Monitor and manage the project schedule including identifying planning gaps and risks, taking initiative to adapt plans/implement mitigations · Provide operational support to affiliates & regions during the planning, launch, and maintenance of GAMs in each participating country · Partner with appropriate functions to develop training materials, and provide training to team members on program objectives, timelines, etc. · Participate and present in regular team meetings, track key discussion points, capture actions, and disseminate meeting minutes · Build and maintain GAM team data repository and SharePoint folders · Support external vendor relationship for GAM programs · Highlight dependencies, key decision points, critical activities and map milestones; negotiate and resolve issues as they arise · Continuously evaluate and improve process and governance Qualifications · Bachelor’s degree (advanced degree preferred) and at least 6-9 years of relevant industry experience · Proven experience in coordinating global early access programs and compassionate use requests, CRO experience is a plus · Strong understanding of global early access principles and regulations · A business acumen with strategic ability · Vendor management experience · Strong communication, organizational, project management, and presentation skills · Experience with a Global matrix organization preferred · Expert computer and internet skills including MS-Office products such as PowerPoint, Word, Excel, Project · Demonstrated cross-functional experience with the ability to navigate complex environments · Provides technical guidance to employees and/or supervisor · Solves complex problems; decisions and problem solving are guided by policies, procedures, and department plans · Ability to work independently, with minimal guidance Additional Information All your information will be kept confidential according to EEO guidelines.