Principal Medical Writer
- Serves as a primary author who writes and provides input on routine clinical documents such as clinical study reports and study protocols and summarizes data from clinical studies.
- Serves as a primary author who writes complex clinical and scientific and program level documents, including IBs, bioassay reports, INDs, and MAAs.
- Reviews routine documents prepared by early career team members. May provide training and mentorship for writers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
- Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods, and techniques for achieving optimal results, including various client-specific processes.
- May assist in program management activities. Identifies and resolves out of scope activities. Duties could include developing timelines, budgets, forecasts, and contract modifications.
- Represents the department at project launch meetings, review meetings, and project team meetings.
- Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- Strong project management skills
- Excellent interpersonal skills including problem solving.
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national, and other document development guidelines
- In-depth knowledge in a specialty area such as preclinical or regulatory submissions, etc.
- Great judgment and decision-making skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g., Excel, Outlook).
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