Director, Medical Review

Overview

The Director, Medical Review plays a key role within the Medical Affairs organization and is responsible for ensuring medical and scientific accuracy of promotional and non-promotional materials in compliance with US laws and regulations. Director of Medical Review will play an important role in contributing to overarching medical affairs strategy, initiatives, and lead the content review process to support timely, high-quality medical and promotional materials. This role will work closely with cross-functional teams including Medical Affairs, Regulatory, Legal, Compliance, and Marketing.  This role will play an important role in upholding the standards of scientific exchange, promotional communications, and regulatory compliance. This role is responsible for leading the Medical Review contribution to both promotional material approval process (MAP) and medical material review process (MedRP) to ensure regulatory and scientific standards are met while fostering collaboration and partnership with cross functional stakeholders and assigned committees. This role will establish and report on key performance metrics to Medical Affairs Leadership, manage documentation and systems material review responsibilities, and cultivate cross-functional collaborations to achieve organizational objectives.

Responsibilities

• Lead the Medical Review function and responsibilities, partner and collaborate with Medical Affairs colleagues and key internal partners include Regulatory, Legal, Compliance, Marketing, and Commercial
• Represent Medical Affairs in Functional and Operational Meetings as it pertains to the Promotional Review Process and Best Practices
• Provide feedback and recommendations to optimize and improve Veeva practices, operations, and workflows
• Manage, coach, and mentor those involved in the medical review function and material review process
• Lead and provide the medical and scientific review of promotional and non-promotional materials to verify data accuracy, proper substantiation, and consistency with clinical study reports, clinical guidance, and scientific literature
• Collaborate with material owners and reviewers to clarify data interpretation and ensure alignment across assigned therapeutic areas
• Grant formal approval via signature authority for the 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.
• Contribute content-specific insights to ensure external communications meet regulatory and scientific expectations and align with medical and brand strategy
• Participate in review meetings (MAP, MedRP, etc.) providing medical input on disease education, product communications, pipeline materials, training documents, etc.
• Medical review of other materials pertinent to Xeris business as required, including Medical Education materials and internal medical and scientific slides/papers/manuscripts.
• Lead, participate, provide training materials and activities as it pertains to medical, sales, and commercial colleagues as assigned
• Coach and mentor interns and students on rotational experience as assigned
• Conduct comprehensive gap analyses to identify unmet medical review needs and formulate actionable strategies.
• Disseminate actionable medical insights across the organization to enhance content review processes
• Develop and implement ongoing training programs for internal stakeholders to ensure best practices, up to date knowledge, and operational excellence.
• Champion process improvements within Medical Affairs to enhance internal collaborations, partnership, and operational efficiency.

Qualifications

• The qualified candidate will have a doctoral degree in a health science related field such as a PharmD, MD or Ph.D., with a thorough grasp of the pharmaceutical industry.
• Minimum of 5-7 years of relevant experience in the medical review of scientific, training, or promotional content in a pharmaceutical or biotech setting
• Working knowledge of US regulatory standards and promotional review requirements (i.e. FDA, OPDP, etc)
• Demonstrated experience in negotiating and partnering with legal, regulatory, and commercial stakeholders effectively representing organization interest, strategy and ensuring full compliance with all relevant laws and regulations
• Well-versed in highly technical and scientific languages to communicate with key internal and external stakeholders.
• Highly effective in maintaining productive working relationships across multidisciplinary teams
• Proven ability to lead teams, mentor staff, and collaborate cross-function