Senior Medical Writer

  •  

Boston, MA

Industry: Pharmaceuticals & Biotech

  •  

Less than 5 years

Posted 2 days ago

  by    Faya Lou Bea

Job Summary

Title: Senior Medical Writer

Company: Pharma / Biotech Company

Type: Permanent Role

Notes: No Corp to Corp

Responsibilities:

  • Draft, edit, format, and finalize documents including, but not limited to: clinical protocols and amendments, investigator's brochures (IBs), clinical study reports (CSRs) and development safety updatereports (DSURs).
  • Provide quality control (QC) review of clinical and regulatory documents including data output.
  • Produce high quality and on-time writing deliverables ensuring scientific consistency between related documents or studies in a clinical program.
  • Ensure a consistent style of presentation of clinical documents to maintain quality and ease of review, and adherence to company standards.
  • Facilitate efficient review and finalization process of documents produced internally and externally by contractors and vendors.
  • Assisting in the development of templates and standard operating procedures (SOPs).
  • Representing Medical Writing on one or more programs

Requirements:

  • Advanced degree (MS or PhD) in a relevant scientific field.
  • A minimum of 3 years medical writing experience in a pharma, biotech, or a combination of CRO and pharmaceutical setting with in-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
  • Strong written and verbal communication skills, with the ability to clearly present clinical data.
  • Regulatory submissions and knowledge of eCTD formatting preferred.
  • Oncology experiencepreferred.