Principal Medical Writer Job Description Template
Our company is looking for a Principal Medical Writer to join our team.
Responsibilities:
- Propose and participate in departmental continuous improvement initiatives;
- Perform formal literature searches, and succinctly summarize scientific content for assigned projects;
- Assist in training staff;
- Author clinical trial protocols, interim and final clinical study reports, integrated safety/performance data summaries from raw data;
- Collaborate with other staff to resolve complex or unclear situations;
- Write and coordinate the development of protocols, CSRs or other clinical documents of any complexity;
- Collaborates cross-functionally to provide input for design teams for Clinical EU MDR documentation;
- Provide input on data analysis planning and interpretation;
- Write clinical study reports, protocols, clinical development plans, FDA briefing documents, and IND, NDA, and MAA modules;
- Coordinate quality assurance reviews of documents and maintaining audit trails of changes; and.
Requirements:
- Master’s degree and 5 or more years of medical writing experience;
- Prior experience in the research, pharmaceutical, or medical device industry preferred;
- Proven reviewing experience in a medical communications agency;
- Strong communication skills, both oral and written;
- Approximately 6–8 years’ medical communications agency experience in editorial roles;
- A life sciences degree, ideally combined with a science Masters or PhD;
- Extensive onsite and client meeting experience;
- Strong computer skills, project management skills, and a high attention to detail; and;
- Extensive medical writing experience from a medical communications or pharma environment across a broad range of projects and therapeutic areas.