Sr/Principal Medical Writing Scientist at Vertex in Boston, MA

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Job Description:

Location: onsiteBoston, MA

Vertex's Medical Writing department is hiring a Principal Medical Writing Scientist. Our Medical Writers are key members of study and submission teams. Our team consist of about 25 people who prepare clinical regulatory documents to support development programs throughout the product lifecycle.
As a Principal Medial Writing Scientist you are responsible for preparing complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development. You are scientific contributor and subject matter expert for clinical regulatory documentation, and you will work with 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
  • Actively identify process and template improvements
  • Provide expert-level input to teams that work on standard operating procedures and process improvements, and integrations of new tools and technologies
  • May train, mentor, and supervise staff
  • Perform other duties as assigned
Technical and Communicative Skills:
  • Excellent 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 working relationships, and work through conflicts
  • Prioritization skills and ability to handle multiple complex projects
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Qualification:

  • Master's Degree or PhD (or equivalent degree) and 4+years of relevant work experience

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