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    Medical Writing Senior Manager

    Vertex Pharmaceuticals
    Boston, MA 02210
    Full-time
    Refer friends, get paid!

    Job Description

    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

    Posting ID: 584153557Posted: 2021-01-10