Principal Medical Writer at Dicerna Pharmaceuticals
Principal Medical Writer – Temp to Permanent
The Principal Medical Writer (PMW) is an expert in medical writing and performs work independently with minimal supervision. The PMW will work closely with Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs to manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The PMW will provide high level strategic input into development plans, study designs, and regulatory submissions. The PMW may supervise other medical writers.
- Efficiently prepare high-quality, strategically aligned deliverables that support the clinical and regulatory requirements of a clinical development program, including protocols, study reports, Investigator Brochures, CTD modules, regulatory meeting requests and briefing packages, and responses to competent authority requests.
- Provide advanced input into study designs, analysis plans, and regulatory submissions/ applications.
- Analyze proposed study plans and related documents for their ability to deliver the information required by the target audience.
- Collaborate with others to develop key messages for complex clinical regulatory documents.
- Interpret and accurately present clinical and statistical data in a clear, concise format.
- Plan and lead document review meetings to achieve consensus on document strategy, content, and format. Independently resolve document content issues and questions arising during the writing process.
- Review and edit documents written by other project team members.
- Mentor and lead less experienced medical writers on complex projects, as necessary.
- Minimum of bachelor’s degree, preferably in a health-related or scientific discipline
- Minimum of 7 years clinical/regulatory medical writing experience in a pharmaceutical, biotechnology, or CRO environment, with extensive experience independently writing and/or editing clinical protocols and protocol amendments, CSRs, CTD modules, regulatory briefing documents, and responses to competent authority queries
- Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines
- Demonstrated understanding of statistical approaches in clinical study design and analysis
- Exceptional written and oral communication skills, with mastery of English grammar and punctuation
- Expert-level MS Word skills. Experience with StartingPoint and Sharepoint desirable
- Ability to manage complex projects with minimal supervision
- Ability to work well under pressure and adapt to change as needed
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