Manager, Medical Writing
The Manager, Medical Writing will prepare and review clinical/regulatory documents to support all phases of clinical drug development. The position will work closely with an interdisciplinary team to ensure documents are of high quality and comply with internal and external standards. This position will also assist in the development of internal standards and templates.
ESSENTIAL DUTIES AND RESPONSIBILITIES (include, but are not limited to):
- Plan, write, edit, format, and finalize clinical/regulatory documents, including, but are not limited to, clinical study protocols, clinical study reports, investigator brochures, annual safety updates, clinical summary documents, and other regulatory submissions.
- Collaborate with Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, and other departments to draft and finalize documents.
- Effectively lead data interpretation and comment resolution meetings, and manage timelines for medical writing projects.
- Represent Medical Writing on project teams ensuring proper document preparation and documents are finalized within timelines.
- May manage internal personnel, independent consultants and/or third-parties to ensure delivery of high quality documents.
- Ability to interpret and present scientific and clinical trial data, as well as understand statistical analyses. Ability to strategically present data/results.
- Commitment and ability to producing high quality documents that comply with internal and external standards.
- Must possess strong skills in leadership, communication, creativity, and the ability to work well both independently and as part of a team. Must be able to effectively manage and implement multiple projects.
EDUCATION and/or EXPERIENCE:
- PhD degree in the life sciences or MS degree and equivalent experience, and at least 4 years relevant work experience as a medical writer.
- Experience authoring clinical NDA documents (e.g., ISS/ISE, Summary of Clinical Efficacy/Safety) is highly preferred.