Director, Medical Promotional Review

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary:

The Director, Medical Promotional Review, plays a key role in the Medical Affairs team and is responsible for ensuring medical and scientific accuracy of promotional and non-promotional materials in compliance with US laws and regulations and company policies. The position involves reviewing all materials submitted to the Medical Review Committee (MRC) and Medical Legal Regulatory (MLR) promotional review committee to ensure regulatory and scientific standards are met, while fostering collaboration with Legal and Regulatory teams to maintain compliance and quality. In addition, the Director, Medical Reviewer will work with the strategy team on content creation, ensuring the data is accurate. The Director, Medical Reviewer will report to the Executive Medical Director, Therapeutic Area Head.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Serve as Medical Reviewer in MRC and MLR, ensuring all medical materials are medically accurate, balanced, scientifically accurate, non-misleading, relevant, and unbiased, in collaboration with Legal and Regulatory
• Uphold/improve MRC/MLR processes (e.g., references are correctly annotated, strength of evidence in reference is appropriate, rationale for comments/requested changes are sufficiently backed)
• Collaborate with medical affairs, regulatory, legal and commercial teams and utilize Veeva PromoMats to review promotional and non-promotional materials in a timely manner
• Work with strategy team to contribute to medical content creation, ensuring messaging is accurate.
• Collaborate with project owners to resolve comments and ensure compliance
• Attend all scheduled MRC and MLR meetings as required
• Provide clear guidance to project owners to ensure efficient and appropriate submission of materials through the review process including through weekly office hours as needed
• Work with the MRC and MLR administrator to optimize review planning and establish the agenda
• Provide feedback to improve Veeva PromoMats review workflows for different material types
• Stay updated on FDA regulations and industry trends relevant to medical and promotional materials development
• Proficiency in technologies and CRM systems for reviewing medical and promotional materials (e.g., Veeva PromoMats and/or MedComms)
• Excellent written and oral communication skills
• Demonstrated ability to analyze, concisely, timely, and accurately summarize, and present complex scientific and medical data to a diverse audience of both scientific and non-scientific professionals
• A commitment to producing high-level results and performing duties with integrity
• Ability to work independently and within a group setting
• Excellent organizational skills
• Must be competent in problem solving and sound decision-making
• Strong attention to detail and demonstrable ability to identify and correct errors
• Aptitude for conflict resolution and de-escalation
• Performs other duties and responsibilities as assigned

Education and Experience:

Required:

• Advanced/doctoral degree (PharmD, PhD) with 10 years of experience in a health/biological sciences required, plus a minimum of 8 years of experience in a supervisory/leadership role
• Minimum 8 years of experience as a medical reviewer in appropriate functions (e.g., Medical Affairs, Medical Information, or Scientific Communications)
• Prior experience reviewing medical materials including Field Medical slide decks, Medical Information response documents and frequently asked questions, medical booth congress materials, congress presentations, scientific communications platforms, clinical pathway submissions, and AMCP dossiers
• Prior experience reviewing promotional materials including print and digital advertisements (websites, core visual aids, leave behinds, rep triggered e