Sr. Manager, Medical and Promotional Review
200 Tech Square Cambridge, MA 02142 US
(Target PR: 60-76/hr)
*Depending on experience
The Sr. Manager, Medical and Promotional Review will be a contributing member of the Medical Review Committee (MRC) and the Promotional Material Review Team (PMRT). The Sr. Manager will be responsible for the review and approval of medical and promotional pieces, working closely and collaboratively with other reviewers and stakeholder groups such as medical, legal, and regulatory (MLR), compliance, and commercial teams. This individual will ensure that materials are scientifically and medically accurate, statements are adequately supported and up-to-date, and not misleading. This individual will also verify accuracy of cited data and that content is consistent with current medical opinion according to published literature or guidelines.
Heres What Youll Do
Serve as the medical reviewer for materials in the MRC and PMRT process, as well as other review committees as needed.
Provide medical insights and leverage therapeutic medical expertise for MRC, PMRT, and other review committees.
Ensure medical accuracy of all materials, including but not limited to disease awareness materials, pipeline materials, marketing materials and internal use materials.
Support cross-functional collaboration; help align US and Global Medical Affairs projects as needed.
Support the MRC process, providing guidance, training, and vendor support as needed.
Maintain a high knowledge of new data and developments within all therapeutic areas and proactively advocate medical and scientific positioning of products.
Heres What Youll Need (Minimum Qualifications)
3+ years of job relevant experience in a Medical or Promotional Materials Review Committee
Experience working in Veeva Vault
Experience working in Medical Affairs in the biotechnology or pharmaceutical industry
Experience and knowledge of FDA, EU, ICH guidelines and regulations.
Heres What Youll Bring to the Table (Preferred Qualifications)
Prior experience in infectious diseases and/or vaccines is preferred
Proven ability to effectively manage interactions with internal and external agency partners.
Ability to interact with cross-functional teams in a matrixed organization.
Well-organized self-starter, hard-working and independent.
Strong negotiation, verbal/written communication, and interpersonal skills with a good awareness of global cultural differences.
Excellent attention to detail.
Strong written and verbal communication skills.
Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
- Looking for 2-3 days a week in office in Cambridge
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