Principal Med Writer

Role overview

Principal Med Writer at Thermo Fisher Scientific

Employment details

• Location: Remote [India]

Benefits

• Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.

Additional role details

• As the lead writer, reviews documents for the team and provides training and guidance to junior team members.
• Provides advice on document development strategy, regulations and industry best practices.
• Demonstrates subject matter and therapeutic area expertise.
• Acts as backup program manager.
• Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
• Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies.
• Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies. - Serves as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs. - Provides senior level review of routine and complex documents.
• Provides training and mentorship for other writers and program managers 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.
• As the subject matter expert, develops and reviews best practices, methods and techniques for achieving optimal results, including various client-specific processes, and leads process improvement initiatives.
• May also develop, review and manage performance metrics for assigned projects. - May serve as backup program manager.
• Identifies and resolves out-of-scope activities.
• Duties could include developing timelines, budgets, forecasts and contract modifications, and assisting business development with client presentations and proposal text review and attending bid defense meetings and capabilities presentations. - Represents the department at project launch meetings, review meetings, and project team meetings.