What are the responsibilities and job description for the Associate Director, Medical Writing position at Sarepta Therapeutics?
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
The Importance of 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. The Associate Director, Medical Writing 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 MW 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.The Opportunity to Make a Difference
- Plan, prepare, write, edit, format, and finalize clinical and regulatory documents. Documents will include, but are not limited to: clinical protocols, clinical study reports, Investigator's brochures, Module 2 summaries of registration dossiers, annual updates to regulatory submissions, briefing books, and regulatory responses.
- Represent Medical Writing on project teams and, as such, advise teams on content and format requirements for various documents, as well as coordinate writing activities for document development (eg, timelines and review/revision responsibilities) with the project teams.
- Coordinate deliverables with external vendors.
- Ensures compliance within the company, maintains knowledge of regulations, product areas, current trends, and current literature.
- Creates and maintains SOP and other MW governance documents.
- Leads efforts to identify and solve for compliance or efficiency gaps in processes.
- Participates in meetings and activities to enhance cross functional alignment between electronic document, quality, and TMF systems management.
- Provides metrics on MW performance and takes action to assure alignment with corporate, department and functional goals.
- Member of the Global Regulatory Team for assigned products.
- Provides product and platform writing and strategy support to cross-functional teams.
- Provides mentoring.
- Supports development, onboarding, and training for direct reports and MW team.
- Assures adherence to MW processes and compliance with applicable regulations.
- Plays a critical role in the execution of MW documents, ensuring adherence to MW processes and compliance with applicable global regulations.
- Active participant in the GRA department, CTT, and CDT.
- Supports objectives that have critical impact.
- Strives for alignment with organizational business objectives both within GRA and cross-functionally.
- Escalates and effectively communicates issues to supervisor and other related MW stakeholders.
More about You
- Bachelor's degree or equivalent; life sciences is 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 is essential, as well as 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 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.
What Now?
We're always looking for solution-oriented, critical thinkers.
So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
Salary : $156,000 - $195,000
