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Job DescriptionAbout the role:As a member of Takeda Oncology, your work will contribute to our bold, inspiring vision: We aspire to cure cancer. Here, you'll build a career grounded in purpose and be empowered to deliver your best. As part of the Global Medical Affairs Oncology Evidence Generation team, you will report to the Lung Evidence Generation Lead/ Medical Affairs Company Sponsored (MACS) Program Leader and work with various departments and functions.
How you will contribute:Assists with study tasks under the supervision of Investigator-Initiated Research (IIR), Externally Sponsored Collaborative Research, and MACS Study Leads
Works closely with field staff, local representatives, principal investigators and his/her staff to ensure appropriate submissions of all required study documents
Responsible for processing and facilitating activities associated with Concept, Protocol and Protocol Amendment Reviews
Manages internal study designated website/database systems, including but not limited to: business requirements, administration, and processes
Ensures communication and information sharing occurs between cross functional groups and study sites as appropriate
Coordinates with investigator/site for study updates and receipt of publications/study report
Study drug management and tracking
Submits and maintains purchase order requests, supplier registrations, and invoices in central finance system for IIR, Collaborative Research, and MACS
Assists in the preparation and documentation of the Fair Market Value (FMV) Analysis of research budgets for IIR, MACS, and Collaborative Research studies
Assists with budget management and reporting for GMAO Evidence Generation activities
Coordinates the execution of Confidentiality Agreements and contracts via a legal tracking system
Minimum Requirements/Qualifications:Bachelor's degree in a science and/or engineering field preferred or any Bachelor's degree and 2+ years of clinical research experience
Thorough understanding of FDA, EMEA, ICH, and GCP guidelines preferred, as well as understanding of cross-functional clinical processes including data management, biostatistics, budgeting, medical writing, drug safety, regulatory affairs, and legal affairs
Working knowledge of MS Office Software including Excel and Word
Ability to manage multiple priorities
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:
Boston, MAU.S. Hourly Wage Range:
$26.92 - $42.31The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 hourly wage 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 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.
LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
NoIt 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.