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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Keywords: Takeda, Providence , Manager or Sr. Manager, GMA Global Medical Evidence Operations, Neuroscience, Executive , Boston, Rhode Island
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