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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?

Role Objectives

• Accountable for overseeing RWE Medical Affairs Company Sponsored (MACS) study preparation in different Therapeutic Areas for both in line and pipeline products with the support of the relevant Evidence Generation Lead and Medical Lead/Head
• Accountable for supporting internal submissions, Feasibility Assessments and study activations of global MACS studies
• Accountable for overseeing RWE Study Execution and study plans (including Study Management Plan and Risk Assessment Plan)
• Responsible for engaging with external vendors/CROs at selection/contracting and for overseeing vendors/CRO activities through the end of the study
• Responsible for maintaining and overseeing the TMF until study close-out and reporting
• Responsible for the conduct of studies in accordance with all applicable internal legal and compliance policies (SOPs) as well as applicable regional or country specific regulatory guidelines

Accountabilities

• Support the preparation of study synopsis and study protocol of global RWE studies in different Therapeutic Areas with the support of the relevant Evidence Generation Lead and Medical Lead
• Prepare RFPs, detailed timelines and budget and establish a contract / SOW with selected CRO
• Support/manage initial submissions and manage study start-up, activation, implementation, execution, study close-out and reporting activities, including overseeing study related documentation and plans (e.g. Study Management Plan, Risk Assessment Plan, etc.)
• Participate in Steering Committee Meetings and provide regular updates on study progress
• Maintain and oversee the TMF and relevant study repositories and central study management systems until study closure / reporting
• Manage study implementation and study execution in accordance with Takeda policies and procedures

Key Capabilities

• Knowledge in outcomes, Real-World Evidence studies and Epidemiologic research
• Project Management experience with a proven track record in study start-up and execution
• In-depth knowledge of GCP, GVP and GPP
• Advanced knowledge of the pharmaceutical industry, including experience with data generation within life-cycle development and knowledge of clinical studies and associated documents and systems
• Extensive knowledge of regulations and industry standards applicable to RWE studies
• Vendor management experience
• Experience managing study management systems and study document repositories

Education, behavioral competences and skills

• Minimum MSc degree (preferably PhD), preferably in a health sciences related field with 6 years of research related experience and/or pharmaceutical industry experience (including CRO)
• Strong written and verbal communication skills (English)

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:

USA - MA - Cambridge - Kendall Square - 500

U.S. Base Salary Range:

$108,500.00 - $170,500.00

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. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

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.

LocationsUSA - MA - Cambridge - Kendall Square - 500

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull 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.