Associate Director, Medical Writing

About the role

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

As an integral part of the clinical team, the Associate Director, Medical Writing will independently plan, develop, and deliver high quality, strategically aligned clinical and regulatory documents. This role is responsible for ensuring high quality with regard to scientific content, organization, clarity, accuracy, adequacy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes, and provides leadership and subject matter expertise and strategy for medical writing planning and coordination. The person in this role must be able to work effectively in a team environment and must have strong scientific, interpretive, organizational, and project management skills.

Responsibilities

• Plan, prepare, write, edit, format, and finalize clinical and regulatory documents including clinical protocols, clinical study reports, Investigator's brochures, Module 2 summaries of registration dossiers, annual updates to regulatory submissions, briefing books, and regulatory responses
• Provide product and platform writing and strategy support to cross-functional teams
• Represent Medical Writing on project teams, advise teams on content and format requirements for various documents, and coordinate writing activities for document development (e.g., timelines and review/revision responsibilities) with project teams
• Play a critical role in the execution of medical writing documents, ensuring adherence to medical writing processes and compliance with applicable global regulations
• Collaborate cross-functionally to drive best practices, implement lessons learned, and improve future capabilities to enhance the effectiveness of compliant clinical trial execution and "Real Time" Inspection Readiness
• Ensure compliance within the company, maintain knowledge of regulations, product areas, current trends, and current literature
• Create and maintain SOP and other medical writing governance documents
• Lead efforts to identify and solve for compliance or efficiency gaps in processes
• Participate in meetings and activities to enhance cross-functional alignment between electronic document, quality, and TMF systems management
• Provide metrics on medical writing performance and take action to assure alignment with corporate, department, and functional goals
• Serve as a member of the Global Regulatory Team, Clinical Trial Team, and other sub-teams (as needed) for assigned products
• Support development, onboarding, and training for direct reports and medical writing team
• Mentor colleagues as needed
• Support corporate objectives that have critical impact
• Strive for alignment with organizational business objectives both within GRA and cross-functionally
• Escalate and effectively communicate issues to supervisor and other related medical writing stakeholders

Requirements

• Bachelor's degree or equivalent; life sciences preferred
• 10+ years of relevant experience, with 8+ years of medical writing or other writing experience
• Excellent writing skills
• Ability to understand, interpret, and communicate clinical and scientific data
• Knowledge of drug development process, current regulatory requirements, and guidelines applicable to GCP/ICH/eCTD compliant documents
• Previous experience with NDAs/BLAs with active contribution in preparation and writing of clinical and regulatory documents
• Proven ability to multitask, deal with competing priorities, and meet aggressive timeline expectations
• Experience and success in working with cross-functional teams
• Excellent interpersonal and communication skills
• Proven flexibility/adaptability to work in a fast-paced and dynamic environment
• Knowledge and application of Good Clinical Practice, Good Documentation Practices, International Council for Harmonization E6(R2), and guidelines ALCOA+ standard
• Approachable with track record for building excellent constructive, positive, collaborative relationships
• Demonstrated project management experience
• Advanced proficiency in MS Office Suite and ability to quickly learn new electronic applications
• Must be authorized to work in the U.S.

Benefits

Sarepta offers a range of benefits and work-life resources designed to support employees in the following areas: Physical and Emotional Wellness, Financial Wellness, and Support for Caregivers. A comprehensive benefits package is available; see the company website for a full list. Sarepta Therapeutics offers a competitive compensation and benefit package.

Pay

The targeted salary range for this position is $160,800 - $201,000 per year. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Schedule

This position is hybrid; you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend company-sponsored in-person events from time to time.