About the Company
Our client, a leader in gene therapy, is currently seeking an Associate Director of Medical Writing to join their team. This is a highly-visible role inside a phenomenal work culture, and a chance to work amongst the top-talent in medicine and make a difference in people's lives.
The Associate Director, Medical Writing will be responsible for developing clinical documents in accordance with all applicable regulations, and submission of regulatory documents to the FDA and EMA. Key responsibilities include:
- Producing high quality and on-time writing deliverables.
- Independently planning, writing, editing, and formatting key documents, including clinical protocols, IBs, clinical study reports, integrated safety and efficacy summaries and related documents.
- Efficient review and finalization processes for documents produced internally and/or externally by contract writers as needed
- Recruiting and mentoring of staff and budget planning
- Collaborating effectively with Biometrics, Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications, as well as with external stakeholders.
- PhD and 5+ years of experience as a medical writer in the sponsor and/or CRO setting. Experience with regulatory submissions (CTA/IND/NDA/BLA) and knowledge of eCTD formatting needed.
- In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
- Successful track record of managing multiple projects in a fast-paced and deadline-driven environment.
- Impeccable attention to detail and ability to complete writing assignments in a timely manner. Experience overseeing the work of contract writers is a plus.
- Proficiency with Microsoft Windows, Word, Excel, and PowerPoint required, familiarity with Excel, QUOSA, and PleaseReview an advantage
If you are interested in this position, please send your resume to firstname.lastname@example.orgHelp immediately