GlobeNewswire

Medical Director

• Writes, edits, and collaborates with program team members on a variety of regulatory documents including protocols, investigator brochures, clinical study reports, CTDs, and briefing books
• Reviews, edits, and ensures quality of documents or sections of documents prepared by functional area representatives as required and ensures adherence to standards
• Oversees document review comment resolution meetings
• Contributes to overall project management and to cross-functional working groups as needed to facilitate efficient development and finalization of clinical and regulatory documents for submissions
• Supports the development of best practices for authoring and reviewing, with a focus on continuous process improvement

Director, Medical Writing

• Lead the planning, authoring, review, and completion of clinical and regulatory documents required for submissions to the FDA and other global health authorities
• Manage internal and external medical writing resources to deliver accurate, high-quality documents on time and in accordance with established standards
• Author, edit, and collaborate with cross-functional team members on key documents, including protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and related submission materials
• Review and refine documents or document sections prepared by functional contributors to ensure quality, consistency, scientific accuracy, and adherence to company and regulatory standards
• Contribute to project planning and cross-functional working groups to support efficient development, review, approval, and finalization of submission-ready documents
• Establish and continuously improve medical writing processes, templates, and best practices to increase quality, consistency, and operational efficiency

• Establish and lead the medical information function, including strategy, processes, and execution
• Establish scalable medical information infrastructure, including inquiry intake, documentation, and response workflows
• Oversee the implementation and training of the medical inquiry intake portal and call center vendors and manage relationships going forward
• Develop high-quality medical information response documents (standard response letters, FAQs, backgrounders) and maintain medical information content aligned with product labeling, clinical data, and evolving scientific evidence
• Lead and oversee Medical, Legal, and Regulatory (MLR) review
• Ensure responses are scientifically accurate, balanced, up-to-date, and compliant with regulation
• Ensure appropriate escalation and coordination of safety, quality, and off-label inquiries
• Analyze inquiry trends to identify knowledge gaps, unmet medical needs, and opportunities to inform medical strategy
• Monitor metrics and quality indicators to ensure continuous improvement and compliance

Senior Director, Medical Information

Director

• Develop and lead U.S. pricing and contracting strategies across assets, including launch pricing, lifecycle management, and portfolio optimization
• Establish pricing frameworks, governance processes, and decision-making forums to enable disciplined execution and compliance
• Translate clinical, economic, and real-world evidence into differentiated pricing and access strategies
• Provide strategic recommendations on pricing, reimbursement, and access trade-offs to support business objectives
• Lead gross-to-net (GTN) strategy, including forecasting, modeling, and performance management across commercial and government channels
• Develop robust pricing and contracting analytics, including payer landscape assessment and contract performance tracking
• Partner with Finance to evaluate pricing and contracting scenarios and support accurate forecasting and revenue planning
• Oversee development of financial models (rebates, discounts, pricing scenarios, share shifts) to inform decision-making
• Ensure operational excellence in contract execution, including rebate processing, chargebacks, and claims adjudication
• Provide oversight of government pricing calculations and reporting, including AMP, Best Price, ASP, 340B, FSS, Medicaid, and Medicare
• Ensure compliance with federal and state pricing regulations and evolving policy requirements
• Oversee reporting processes, audit readiness, and vendor coordination
• Monitor legislative and regulatory developments and assess implications for pricing and access strategies
• Partner closely with Market Access, HEOR, Finance, Legal, Compliance, Commercial, Medical, and Government Affairs teams
• Serve as a strategic advisor on pricing, contracting, and access decisions across the organization
• Engage with external stakeholders, including payers, GPOs, specialty pharmacies, and vendors
• Build, lead, and develop a high-performing pricing and contracting team
• Foster a culture of accountability, innovation, and continuous improvement, while managing resources in alignment with business priorities

Senior Director, Pricing & Reimbursement

Legal Assistant

• Assisting attorneys and paralegals across the Legal department on a variety of legal projects aligned with both business needs and the intern’s areas of interest
• Conducting legal research and analysis to support ongoing matters and strategic initiatives
• Assisting with the review and drafting of basic agreements
• Supporting the preparation and review of patent and trademark filings
• Assisting with the review and preparation of distribution agreements and SEC submissions
• Researching an area of law relevant to Sarepta and drafting a comprehensive memorandum summarizing findings and recommendations

Director, Medical Writing

Director, Medical Writing

Senior Director, Medical Information

Senior Director, Pricing & Reimbursement

Law Clerk – Co-op