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Job Description

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.

Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

About 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.

Empowering our people to shine

At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.

Diversity, Equality, and Inclusion

Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.

If you are interested in this opportunity, we look forward to receiving your application via our online tool!

Learn more at takedajobs.com

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