Associate Director, Medical Information and Review

Role Summary:

The Associate Director, Medical Information and Review plays a critical role in building and executing Dyne’s Medical Information and medical review capabilities as the organization advances toward commercialization and launch readiness. This role serves as a key Medical Affairs partner in the review of promotional and non-promotional materials, ensuring scientific accuracy, medical integrity, fair balance, and alignment with applicable regulatory, legal, compliance, and company standards. The Associate Director also helps develop and maintain high-quality, scientifically balanced Medical Information content, supports inquiry management and vendor oversight, and translates medical inquiry trends, literature, and congress insights into actionable recommendations for internal stakeholders.

This role is based in Waltham, MA.

Primary Responsibilities Include:

• Serve as the core Medical Affairs reviewer within medical and promotional review processes, including Medical, Legal, and Regulatory review committees, ensuring scientific accuracy, integrity, fair balance, and appropriateness of promotional and non-promotional materials
• Establish and maintain thorough medical, scientific, clinical, disease-state, and product knowledge to serve as a primary Medical Information subject matter expert on Dyne’s product portfolio, with a focus on neuromuscular diseases and launch readiness priorities
• Support Medical Information readiness for product launches and contribute to ongoing support and strategic management across all stages of the product lifecycle by building scalable processes, content libraries, training materials, workflows, and operational best practices
• Assist with day-to-day operations, quality oversight, and vendor/contact center activities for Medical Information inquiry handling to provide high-quality service to external stakeholders, including case documentation, escalations, and response quality
• Analyze reports, metrics, inquiry trends, literature updates, and congress insights for Medical Information activities and communicate actionable insights to internal stakeholders
• Support and participate in congress activities, including execution of pre- and post-congress deliverables, insights gathering, internal readouts, and medical booth representation
• Maintain compliance with applicable FDA regulations, industry standards, organizational policies, and Medical Affairs best practices by ensuring all Medical Information and review initiatives are executed with the highest level of integrity
• Provide backup and operational support for the development and maintenance of Medical Information response documents addressing unsolicited inquiries from healthcare professionals and other stakeholders
• Partner with Regulatory, Legal, Compliance, Commercial, Clinical Development, Scientific Communications, Pharmacovigilance, and other cross-functional stakeholders to support timely, compliant review and approval of materials and advance key organizational initiatives
• Operate with Associate Director-level ownership by leading multiple workstreams, facilitating collaboration, improving Medical Information operations, content governance, review processes, systems, SOPs, training, and inspection readiness in a fast-paced, matrixed biotech environment

Education and Skills Requirements:

• Doctorate degree in a scientific or healthcare discipline required; PharmD, PhD, MD, or equivalent preferred
• 8+ years of relevant experience including 5+ in Medical Information, medical review, medical communications, Medical Affairs, or a related function within the pharmaceutical, biotechnology, or healthcare industry
• Experience serving as a medical reviewer for promotional and non-promotional materials through Medical, Legal, Regulatory, and/or Promotional Review Committee processes
• Strong understanding of FDA regulations, industry guidance, and compliance expectations governing Medical Information, scientific exchange, promotional review, and non-promotional communications
• Experience developing, reviewing, and maintaining Medical Information response documents, FAQs, scientific summaries, or related medical/scientific content
• Ability to interpret and communicate complex scientific and clinical data clearly, accurately, and appropriately for internal and external audiences
• Well versed in medical literature searches, publication review, evidence assessment, and synthesis of scientific information
• Experience supporting launch readiness, Medical Information operations, vendor/contact center oversight, congress activities, or inquiry trend analysis preferred
• Rare disease, neuromuscular disease, or specialty biopharmaceutical experience preferred
• Strong project management, organizational, and process-building skills, with the ability to lead multiple workstreams and improve ways of working
• Excellent written, verbal, and interpersonal communication skills, with demonstrated ability to collaborate, influence, and build trusted relationships across functions
• High attention to detail, sound judgment, accountability, and commitment to compliance, scientific integrity, and Dyne’s mission and values
• Ability to work effectively in a fast-paced, matrixed biotechnology environment with evolving priorities
• Willingness to travel up to 25%, including scientific congresses and internal meetings as needed

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