Principal Medical Writing Scientist
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POST DATE 7/2/2020
END DATE 8/15/2020
Vertex Pharmaceuticals Inc (US)
JOB DESCRIPTIONThe 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.
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