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About the Role
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 ensures high quality scientific content, organization, clarity, accuracy, and adherence to regulatory guidelines, while providing leadership and expertise for Medical Writing planning and coordination. The individual must work effectively in a team and possess 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, advising on content and format requirements and coordinating writing activities.
- Ensure adherence to Medical Writing processes and compliance with global regulations.
- Collaborate cross-functionally to drive best practices, implement lessons learned, and improve future capabilities for compliant clinical trial execution and inspection readiness.
- Maintain knowledge of regulations, product areas, current trends, and 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 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.
- Act as a member of the Global Regulatory Team, Clinical Trial Team, and other sub-teams for assigned products.
- Support development, onboarding, and training for direct reports and the Medical Writing team.
- Mentor colleagues as needed.
- Support corporate objectives with 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.
- 8+ years of medical writing or other writing experience.
- Excellent writing skills.
- Ability to understand, interpret, and communicate clinical and scientific data.
- Knowledge of the drug development process is essential.
- Knowledge of 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 is required.
- 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 a track record for building excellent constructive, positive, collaborative relationships.
- Demonstrated project management experience.
- Advanced proficiency in MS Office Suite.
- Ability to quickly learn new electronic applications.
- Candidates must be authorized to work in the U.S.
Skills
- Medical writing
- Scientific interpretation
- Organizational skills
- Project management
- Cross-functional collaboration
- Regulatory compliance
- Good Clinical Practice (GCP)
- Good Documentation Practices
- International Council for Harmonization (ICH) E6(R2)
- ALCOA+ standard
- MS Office Suite proficiency
Location
- US Based
- Remote
Work Type
- Fully remote
- Hybrid
Experience Level
- 10+ years of relevant experience
- 8+ years of medical writing or other writing experience
- Associate Director
Education Level
- Bachelor's degree or equivalent
Salary/Compensations
- $160,800 - $201,000 per year
Benefits
- Physical and Emotional Wellness support
- Financial Wellness support
- Support for Caregivers
- Competitive compensation and benefit package
About the Company
- Sarepta is at the forefront of genetic medicine, holding a leadership position in Duchenne muscular dystrophy and building a robust portfolio across muscle, central nervous system, and cardiac diseases.
- In 2023, Sarepta launched its fourth therapy and the first ever gene therapy to treat Duchenne.
- Sarepta aspires to maintain a culture that acknowledges people bring their whole selves to work and strives to help everyone integrate their work and personal lives while maintaining productivity.
Equal Opportunity
- Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.