Director, Medical Review

Role Summary

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 and other health agency laws and regulations. This role will be accountable for upholding the standards of scientific exchange, promotional communications, and regulatory compliance. The Director, Medical Review will ensure all materials are aligned with the overarching medical strategy and initiatives, and will work closely with cross-functional teams including Medical Affairs, Regulatory, Legal/Compliance, and Marketing. This role is responsible for providing the Medical Review on both promotional and medical materials as part of the Promotional Review Committee (PRC) and the Medical Review Committee (MRC), respectively, to support timely, high-quality medical and promotional materials and consistency across materials.

Responsibilities

• Lead the Medical Review process of Medical and Promotional materials in partnership with internal stakeholders. Medical Materials may include medical slides, medical training materials, medical education materials, and others. Promotional/Marketing Materials may include advertising materials, speaker training materials, Commercial advisory board materials, and others
• 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
• Work closely with Medical Affairs Communications Leadership to ensure external communications meet regulatory and scientific expectations and align with medical and brand strategy
• Collaborate with material owners and reviewers to clarify data interpretation and ensure alignment across assigned therapeutic areas
• Participate in review meetings providing medical input on disease education, product communications, pipeline materials, training documents, etc.
• Ensure standardization of defined policies, SOPs, and best practices, and provide feedback and recommendations to optimize these processes and workflows
• Partner and collaborate with Medical Affairs colleagues and key internal partners including Regulatory, Legal, Compliance, Marketing, and Commercial
• Represent Medical Affairs in Functional and Operational Meetings as it pertains to the Promotional or Medical Review Process and Best Practices
• Participate in training programs for internal stakeholders to ensure best practices, up to date knowledge, and operational excellence
• Support Medical Affairs with additional projects, as needed

Qualifications

• Doctoral degree in a health science related field (MD, PhD, PharmD, DO) preferred
• Minimum 8-10 years of relevant experience in the medical review of scientific and promotional material in a pharmaceutical or biotech setting
• Working knowledge of US, EU, and Canadian health agency regulatory standards
• Well-versed in scientific and clinical trial knowledge, documents, and vocabulary
• Proficiency in Microsoft Office applications required; knowledge of Veeva systems desirable
• Highly collaborative, exceptional attention to detail, values scientific accuracy, and demonstrates excellent organizational skills

Behavioral Skills

• Curiosity: Keep on exploring uncharted territories. Always ask ‚Äúwhy?‚Äù and more importantly ‚Äúwhy not?‚Äù
• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions
• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals
• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.