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The Associate Director, Medical Review, will serve as a functional expert in the area of Medical Review for their assigned region and products and ensure alignment and integration of process and technology efficiencies in medical review activities across diseases areas for Global Medical Affairs Oncology (GMAO).
The individual in this role must excel in providing advanced medical and scientific review of commerical and medical affairs materials (promotional and non promotional materials) to support the non-promotional and promotional review processes. The Individual in this role will be responsible for performing timely, accurate and detailed scientific/medical review of non-promotional and promotional materials for the US and Global market in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs. He/she ensures Takeda non-promotional/ promotional materials convey accurate, correct and balanced medical/ scientific messages.
In addition, will be required to partner with the Head of Medical Review to deliver as needed high-quality, balanced and timely medical and scientific information deliverables for assigned products upon request from internal business partners. They must provide advanced medical information / clinical expertise for assigned products to internal stakeholders (eg, medical affairs strategy teams, product teams within R&D, commercial Brand teams).
Lastly, this individual may be required to support Medical Review needs and activities for other brands and pipeline products, as well as above brand activities, to ensure a best in class Medical Review function, ensuring Takeda Oncology’s professional standing and integrity with patients, HCPs and the pharmaceutical industry through high-quality and aligned medical communication.
Provide advanced medical and scientific review of medical affairs materials and, promotional materials to support non-promotional and promotional review processes, as well as providing project management support for the medical review process, as needed.
Provide advanced medical and scientific review of promotional and promotional materials with local and regional Regulatory codes applicable for the US region in mind. Experience with the ABPI, EFPIA, and EMEA codes is optional but preferred for this role.
Develop and deliver ongoing Medical Review and MLR process training for internal groups and medical affairs teams to ensure compliance with policies and procedures.
Ensure content is well-substantiated by scientific data (verifying the content is accurately cited/properly referenced); check authenticity and validity of references; determine that references in promotional materials specifically support product claims made in the material; and ensure the context of the reference is appropriately reflected in the promotional claim(s) in the material.
Develop content for the medical affairs booth in collaboration with GMAO stakeholders, as well as supporting third-party vendors. Provide advanced support to product booths at professional scientific meetings and congresses as appropriate. Participate in booth design and congress activities as required.
Serve as the Medical Review subject matter expert on the Global Medical Strategy Team Oncology (GMSTO) meetings for the relevant products/ therapeutic areas.
Design and implement internal communication plans to share metrics
Lead the development and maintenance of departmental procedural guidelines and SOPs.
Coach and mentor interns, fellows, students and Medical Review team members.
PharmD/Doctorate with 5+ years of experience, OR, Masters degree in a scientific discipline with 7+ years of experience, OR Bachelor’s degree in a scientific discipline with 8+ years of experience, all plus commensurate long-term experience within pharmaceutical or biotech industry with a thorough grasp of the pharmaceutical industry
5+ years of healthcare or related experience (managed markets, clinical practice, research or academic) including 3+ years of medical review experience within the pharmaceutical industry
Excellent written and oral communication skills
Advanced PC skills, including MS Word, Excel, Power Point, and SharePoint
Experience overseeing and managing budgets to ensure performance versus targets
Oncology experience strongly preferred
Firm understanding of pharmaceutical clinical development and product life cycle management
Cross-functional team participation within the pharmaceutical or related industry
Preferred Requirements/Qualifications:
Advanced degree (PhD, PharmD or equivalent) in a scientific discipline is preferred
Oncology experience strongly preferred
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. Base Salary Range:
$169,400.00 - $266,200.00
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.
Job Exempt
YesIt 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.