Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
The Manager, Medical Review, will have responsibility for medical review within their assigned Therapeutic Area (TA) and will ensure that all scientific content (e.g., promotional material, training materials/programs, corporate communications and select medical materials) is of the highest scientific quality and is compliant with all relevant policies, procedures, and regulations. This position will participate as a member/medical reviewer of the Product Material Review Team (PMRT) and as a member of the Medical Affairs product team(s) for the assigned TA.
- Ensure timely and comprehensive review of PMR submissions
Assure all medical content meets established scientific standards and is compliant with all applicable policies and regulations
Participate in medical review, providing expertise and guidance as Medical Reviewer on PMRT
Ensure appropriate early medical guidance and scientific direction is provided on promotional strategies and messaging within assigned TA including at all PMRT meetings and through ad hoc meetings with project owners
Proactively communicate with colleagues responsible for PGC medical review to ensure clear understanding of all PGC contingencies on PMRT materials
As needed, identify topics of potential escalation and proactively seek guidance from and align with lead medical reviewer and/or team lead
- Serve as member of the Medical Affairs Teams for assigned TA.
Ensure alignment between medical review and other MIE and MA functions
Partner with MA staff in other functions to drive a consistent, unified medical voice/position across MA
- Lead or participate in new projects/initiatives within MIE and across functions as assigned.
Participate in initiatives/projects to improve medical review function processes, output, and impact
- Stay abreast of and participate/lead discussions as a functional expert on:
Newly available clinical data and promotional content within the assigned therapeutic area
Regulatory milestones, actions and guidance relevant to medical review activities
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
- Master's Degree in health science required
- PharmD preferred
- Ph.D., RPh, RN acceptable
- Minimum of 1 year in a relevant pharmaceutical industry or clinical role required
- Proven track record of working successfully with cross-functional teams to achieve results required
- Understanding and application of relevant regulations, policies and guidance (e.g. OIG, FDA, PhRMA Code etc..) preferred
Ability to travel up to 10%; Travel to scientific congresses and company meetings.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.