Associate Director Medical Writing
Associate Director Medical Writing
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 156000 - 195000
1 Vacancy
Job Description
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 limbgirdle 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.
Were 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 worklife 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: 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 Investigators 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 crossfunctional 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 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 crossfunctionally.
- Escalates and effectively communicates issues to supervisor and other related MW stakeholders.
More about You
- Bachelors 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 crossfunctional teams.
- Excellent interpersonal and communication skills.
- Proven flexibility/adaptability to work in a fastpaced 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
Were always looking for solutionoriented critical thinkers.
So if youre 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.
Required Experience:
Director
Employment Type
Full-Time
