Manager or Sr. Manager, GMA Global Medical Evidence Operations, Neuroscience

Company: Takeda
Location: Boston
Posted on: October 16, 2024

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:You will manage the operational conduct of Medical Affairs Company Sponsored Studies (MACS), Investigator Initiated Research (IIR) and Externally Sponsored Collaborative Research studies for assigned therapeutic areas and product programs. You will also serve as the therapeutic area operational lead for interfacing with internal stakeholders (Global, Regional and Local Medical Leads, TA Medical Heads) and external investigators to develop and execute research plans and manage study budgets/financial aspects of global studies (including invoicing, accruals and forecasting). As part of the Global Medical Evidence team, you will report to the GME Process and Training Excellence Lead.How you will contribute:

• Oversee and/or facilitate receipt, processing, and internal cross-functional review of internal/external study submissions.
• Review research committee materials including study concepts and protocols, meeting minutes, and investigator communications.
• Lead required cross-functional review meetings to review, approve, and track studies and ensure proper documentation and archiving (minutes, team communications, etc.) of review outcomes.
• Coordinate the capture, archiving and reporting of appropriate study level information (including patient safety information) and deliverables.
• Oversee and/or facilitate the management of the internal CTMS and other systems and document repositories per Medical Affairs SOPs and processes.
• Coordinate with Pharmacovigilance, Quality and Regulatory Affairs to respond to external audits and requests from external regulatory bodies.
• Manage the pre-fair market value (FMV) evaluation of proposed study budgets and oversee the conduct of FMV assessments of budgets submitted for approved studies in accordance with Takeda policies and procedures.
• Manages all finance related aspects for global studies - invoicing, accruals and forecasting.
• Support process improvement initiatives and contribute to the development and updates of SOP, Job Aids and training materials.Minimum Requirements/Qualifications:
  • Minimum MS degree required (preferably PhD), preferably in a health-sciences related field with 4 years of research related experience and/or pharmaceutical industry experience.
  • Experience with late-stage clinical studies, research collaborations or RWE
  • Proven track record of project management and demonstrated ability to effectively collaborate with individuals.
  • Ability to communicate and interact thoughtfully, transparently, and appropriately with a variety of stakeholders both internal and external to Takeda.
  • Experience working in a global organization and within matrix structure highly desirable.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
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