Manager GMA Evidence Generation Operations

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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Manager, GMA, Global Medical Evidence Operations where you will manage all aspects of assigned program including Medical Affairs Company Sponsored Studies (MACS), Investigator Initiated Research (IIR), and Externally Sponsored Collaborative Clinical Research studies for assigned therapeutic areas and product programs.   You will Manage TA and product level study budgets and communicate study activities to internal stakeholders.  Oversee and manage the activities of Operations Lead, including the initiation, tracking, completion, and reporting of studies.

You will also be responsible for the conduct of studies in accordance with all applicable internal legal and compliance policies (SOPs) as well as external regional and country specific regulatory guidelines.  May serve as the therapeutic operational area lead for interfacing with internal stakeholders (e.g. GMA, Region and LOC medical leads, TA Medical Heads, alliance partners, etc.) and external investigators to develop and execute research plans and budgets.  

 As part of the Medical Evidence team you will report to the Group Lead, Global Medical Evidence Operations.

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 iEnvision (or equivalent system) 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 MSc degree required (preferably PhD), preferably in a health sciences related field with 4 years of research related experience and/or pharmaceutical industry experience.

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 clients both internal and external to Takeda.

Experience overseeing work of and supporting other individuals with a variety of scientific and non-scientific backgrounds and training

Experience working in a global organization and within matrix structure highly desirable.

What Takeda can offer you:

Comprehensive Healthcare: Medical, Dental, and Vision

Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

Health & Wellness programs including onsite flu shots and health screenings

Generous time off for vacation and the option to purchase additional vacation days

Community Outreach Programs and company match of charitable contributions

Family Planning Support

Flexible Work Paths

Tuition reimbursement

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.

Base Salary Range: $102,200 – $146,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

#RM-LI

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

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Takeda Pharmaceutical Company Limited.
Website : https://www.takeda.com