Dynetherapeutics
Associate Director, Medical Information
Waltham, MA. Posted a month ago
The role
The Associate Director, Medical Information and Review builds and executes medical information and medical review capabilities. This person reviews promotional and non-promotional materials for scientific accuracy and manages medical information content and inquiry trends.
What you will do
- Serve as the core Medical Affairs reviewer for promotional and non-promotional materials
- Establish and maintain medical and product knowledge as a subject matter expert
- Support Medical Information readiness for product launches
- Assist with day-to-day operations and vendor oversight for Medical Information inquiry handling
- Analyze reports, metrics, inquiry trends, and congress insights
- Support and participate in congress activities
- Maintain compliance with FDA regulations and industry standards
- Provide backup support for the development of Medical Information response documents
- Partner with cross-functional stakeholders to support material review and approval
- Lead multiple workstreams including content governance, review processes, and SOPs
Required qualifications
- Doctorate degree in a scientific or healthcare discipline
- 8+ years of relevant experience
- 5+ years 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
- 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
- Well versed in medical literature searches, publication review, evidence assessment, and synthesis of scientific information
- Strong project management, organizational, and process-building skills
- Excellent written, verbal, and interpersonal communication skills
- High attention to detail, sound judgment, accountability, and commitment to compliance
- Ability to work effectively in a fast-paced, matrixed biotechnology environment
Nice to have
- PharmD, PhD, MD, or equivalent
- Experience supporting launch readiness, Medical Information operations, vendor/contact center oversight, congress activities, or inquiry trend analysis
- Rare disease, neuromuscular disease, or specialty biopharmaceutical experience
About the company
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations.