Associate Director, Global Medical Information & Review, Global Medical Affairs Oncology
Posted on: November 20, 2023
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About the role:
The Associate Director, Medical Information and 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 and
information 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
information and Review to deliver as needed high-quality, balanced
and timely medical and scientific information deliverables for
assigned products upon request from internal and external business
partners, health care professionals (HCPs) and consumers. 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) and external stakeholders (eg, HCPs, patients and advocacy
Lastly, this individual may be required to support Medical
Information and Review needs and activities for other brands and
pipeline products, as well as above brand activities, to ensure a
best in class Medical Information and Review function, ensuring
Takeda Oncology's professional standing and integrity with
patients, HCPs and the pharmaceutical industry through high-quality
and aligned medical information and communication.
How you will contribute:
- Provide advanced medical and scientific review of medical
affairs materials and, if required, 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 for this role.
- Utilizing advanced medical information /clinical expertise,
independently oversee, plan, develop, maintain and provide
high-quality, balanced and timely medical and scientific
information deliverables including Standard and Custom Response
Letters, Global Core Response Documents, Clinical Dossiers, and
FAQs, to both internal and external customers.
- Provide guidance and direction to the Medical Information Call
Center staff on handling routine and complex cases; monitor and
manage complex escalated cases from the Medical Information Contact
- 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
- Conduct strategic assessment (gap analysis) of medical
information needs within therapeutic areas and develop fulfillment
strategies. As a result, plan the development of global core
response documents (GCRDs) that are strategically aligned with
regional and local needs, and partner with Global Medical Leads, as
appropriate, to ensure approval of GCRDs.
- 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 Information and 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 and inform medical strategies by disseminating actionable
medical insights and trends on a consistent basis. Lead the
development and maintenance of departmental procedural guidelines
- Coach and mentor interns, fellows, students and Medical
Information & Review team members.
- Bachelor's degree in a scientific discipline 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 information and review experience within the pharmaceutical
- Excellent written and oral communication skills
- Advanced PC skills, including MS Word, Excel, Power Point, and
- 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
- Advanced degree (PhD, PharmD or equivalent) in a scientific
discipline is preferred
- Oncology experience strongly preferred
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
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
- Family Planning Support
- Flexible Ways of Working
- 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
This position is currently classified as "hybrid" in accordance
with Takeda's Hybrid and Remote Work policy.
In accordance with the CO Equal Pay Act, Colorado Applicants Are
Not Permitted to Apply.
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.
Keywords: Takeda, Boston , Associate Director, Global Medical Information & Review, Global Medical Affairs Oncology, Executive , Boston, Massachusetts
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