About the Company
Our client, a global biotechnology company developing innovative treatments for rare genetic and infectious diseases is currently seeking a Medical Writing Manager/Sr. Manager to join their team. This is an opportunity to join a dynamic work environment where employees can and a group of passionate professionals driven by patient-focused first-in-class technology.
The Manager/Sr. Manager, Medical Writing will represent Medical Writing on a Program Team to develop clinical documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs). 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 consultants, contractors and vendors.
- Representing Medical Writing on multiple early phase project teams or on specific late phase project teams to ensure proper planning and resourcing for upcoming project writing deliverables.
- 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.
- Contributing to SOP and template development and maintenance
- Bachelor's degree in Life Science with relevant writing expertise. Advanced degree and/or professional certification/credentials preferred.
- 4+ 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 is a plus.
- 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.
- Ability to travel approximately 10% is required.
If you are interested in this position, please send your resume to firstname.lastname@example.org immediately