"Alerted.org

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 Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

The GMA, Global Medical Evidence Operations Manager 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. The role 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, the position reports to the GME Process and Training Excellence Lead.

How you will contribute:

+ Oversee and/or facilitate cross-functional review of internal/external study submissions.

+ Process review 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, preferably in a health-sciences related field with 2 - 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.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Cambridge, MA

$123,200.00 - $193,600.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement

_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.