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Job

Senior Manager Regulatory Writing

  • Location

    REMOTE

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Fahd Joudi

  • Contact email:

    f.joudi@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • Expiry date:

    2023-05-12

  • Startdate:

    ASAP

Principal/Senior Manager Medical Writing

Your responsibilities include, but are not limited to:

Overall, the Senior Medical Writer is responsible for writing, reviewing, and overseeing the production of clinical, nonclinical, and regultaory documents to support product development and marketing applications.

  • Authoring and managing document review and finalization process
  • Managing timelines for Medical Writing documents you are authoring
  • Reviewing and editing documents written by other functional teams
  • Participating in clinical study team meetings and other appropriate clinical development teams meetings as needed to provide input regarding MW deliverables, timelines, and process
  • Coordinate with subject matter experts (SMEs) and key stakeholders regarding appropriate document content
  • Document authoring includes, but is not limited to: clinical study protocols and amendments, clinical study reports, Investigator’s Brochures, Development Safety Update Reports and other annual reports (eg, ODD annual reports), and CTD sections for IND/NDA submissions and may include authoring of other regulatory documents (eg, briefing documents, responses to information requests)
  • Document editing and reviewing may include: nonclinical and/or clinical pharmacology reports and/or CTD sections, CMC documents (as needed), and other documents as needed
  • Adhere to company Style Guide, templates, and SOPs for document development
  • Participate in the development of departmental SOPs and cross-functional process development in a gowing company

 

Your profile:

  • Fluent in English
  • Excellent and established medical writing skills (at least 5 years experience as a medical writer in industry)
  • Ability to write clean and concise documents
  • Ability to understand and interpret clinical and scientific data
  • Ability to author documents in a manner that is understandable to a variety of audiences
  • Knowledge of current regulatory guidelines including but not limited to ICH guidelines
  • Proficient in MS Word, Power Point, and Outlook
  • Excellent time management skills and the ability to manage multiple ongoing projects simultaneously
  • Ability to build partnerships with key stakeholders from other functions to ensure strategic business goals are met

 

Our offer:

  • Competitive compensation
  • An exciting and multifaceted full-time position
  • Become part of a passionate, creative, and collaborative international team

 

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