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Job

Principle Medical Writer- Boston, MA

  • Location

    Unknown

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Sam Banks

  • Contact email:

    s.banks@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    7 months ago

  • Expiry date:

    2020-06-07

My client is a well-established biotechnology company with an international presence seeking a Lead/Principle Medical Writer on a permanent basis. The client are happy to look up to Director level providing the applicant is willing to be do hands-on writing before looking to build a team in the future with a company that is rapidly expanding over the next 12-18 months

Responsibilities

  • Develop and prepare documents to be submitted to the FDA and EMA including Protocols, Investigator Brochures, Clinical Study Reports, Briefing Documents, and clinical summary sections of CTDs
  • Work cross-functionally with members of Clinical Development teams to maintain consistent messaging strategy
  • Oversee medical writing deliverables completed by third party vendors
  • Review statements in deliverables to ensure they are accurate and supported by appropriate data
  • Establish and maintain Best Practices and SOPs

Qualifications

  • 3+ years writing experience in academic, clinical, or industry setting
  • Experience writing protocols, IBs, and CSRs, submissions experience (IND and NDA) preferred
  • Demonstrated understanding of the clinical development process and the documents required in each phase
  • Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents

This is a great opportunity to take on greater responsibility and advance your career in an organization that values your opinion.

For more information please contact samuel banks either on +347 242 5722 or send your Cv to s.banks@hamlynwilliams.com