Medical Writing Science Senior Manager
Vertex Pharmaceuticals Inc (US)

Job Info

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The Vertex Medical Writing department is a collaborative team responsible for supporting development programs throughout the product lifecycle. Medical Writers are key members of study teams and submission teams. The Principal Medical Writing Scientist is recognized as a scientific contributor and subject matter expert for clinical regulatory documentation. The Principal Medical Writing Scientist will interact with other medical writers, quality control reviewers, and cross-functional teams.

KEY RESPONSIBILITIES:
* Independently prepare clinical regulatory documents, including protocols, study reports, investigator's brochures, and sections of regulatory submissions
* Participate in developing key messages for complex clinical regulatory documents
* Provide medical writing input for study designs and statistical analysis plans
* May be the lead writer for multiple clinical development programs or therapeutic areas
* Provide expert review of documents
* Proactively identify process and template improvements.
* Provide expert-level input to cross-functional teams that work on standard operating procedures, process improvements, and integration of new tools and technologies
* May train, mentor, and supervise staff in the Medical Writing department
* Perform other duties as assigned

TECHNICAL AND COMMUNICATIVE SKILLS:
* Outstanding written communication skills
* Extensive experience writing and editing clinical regulatory documents
* Ability to analyze, interpret, and summarize highly complex data
* Advanced understanding of drug development, clinical research, and regulatory requirements
* Ability to form productive working relationships, and work through conflicts
* Ability to prioritize and manage multiple complex projects

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