The Director, Medical Review will work with the VP, Scientific Communications and assigned US Medical Office (USMO) Medical Team(s) to lead a high performing team responsible for medical review activities across a broad portfolio of products. The Director will also support implementation of USMO medical communication strategies and other scientific communication activities as identified.
Leads the Medical Review activities of promotional materials, press releases, and sales training communications as part of the Medical Regulatory Legal process for the US Business Unit (USBU).
Manage Medical Review Team in the participation and contributions to cross-functional promotional review activities including: 1) providing strategic scientific consults on brand messages, 2) reviewing promotional materials for content and accuracy, 3) coordinate the development and review and approval of clinical data on file to support promotional claims.
Maintains current and up to date knowledge on FDA Regulations and Guidance documents and enforcement action letters as applicable to promotional claims and shares implications with Medical Reviewers to enhance the team s knowledge, understanding, and awareness of best practices.
Leads the Medical Review process, procedures, and documentation of Non-Promotional Medical Review of Medical Materials in partnership with internal stakeholders. Medical Materials may include medical slides, medical training materials, medical education materials, white papers, publications, and other types of medical and scientific material.
Leads, manages, coaches and develops Medical Review personnel to support high performance, alignment with USMO Medical Strategies, and support the delivery of high quality product information, promotional product communications, and other medical and scientific communications. Assesses performance against identified Medical Review functional goals. Create, maintain and communicate metrics and key performance indicators to Senior Leadership.
Determines product and/or functional assignment of Medical Review personnel; mentors Medical Review personnel; oversees the work product and overall performance of Medical Review Team.
Assess new alliance partnerships for resource needs; develops appropriate joint Medical Review policies/processes; collaborates with VP, Scientific Communications and alliance partner in the development of policies/processes that reflect best practices and are in compliance with Takeda policies/processes.
Serve as a Medical Review subject matter expert and key member of identified USMO Product Medical Units and/or identify and empower respective designate(s) to participate.
Engage with key internal stakeholders to support medical and scientific communication activities and support Medical Team goals and objectives, which includes USMO Product Medical Team(s), including Medical/Scientific/Clinical Directors, and other functional medical partners such as Outcomes Research, Field Medical, Regulatory and Advertising, Scientific Communications (Publications, Medical Education), Medical Operations (Program Management Office); other USBU Stakeholders; such as Marketing, Marketing Operations, Legal, Corporate Communications, etc. and Global Medical Affairs and other Shared Services.
Works closely with Scientific Communications Leadership Team to ensure standardization within the Medical Review department of defined policies, SOPs, and best practices.
Ensures overall team is maintaining a comprehensive knowledge of therapeutic area, product(s), and health ecosystem developments by participating in relevant team and company meetings, attending scientific congresses, and a commitment to continued professional development.
Responsible for insuring the team s management of documents and/or business systems utilized for completion of medical review activities
- Minimum of a PharmD, Ph.D, or MD.
- Minimum of 7 years of experience within Medical & Scientific Affairs or related industry experience.
- At least 3 years of managing people.
- Excellent written and oral communication skills.
- Significant understanding of issues in medical review.
- Post-doctoral residency or fellowship, or sufficient applicable experience.
- Significant experience and knowledge of clinical trial reports, data presentation, interpretation, and communications
Willingness to travel to various meetings or client sites, including overnight trips. Some international or weekend travel may be required.
Requires approximately 5-20 % travel.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.