Senior/Principal Medical Writer

The Senior/Principal Medical Writer is responsible for the medical writing deliverables that support the clinical oncology portfolio at Boston Biomedical Inc.  The Senior/Principal Medical Writer will assist in preparing moderately complex clinical study documents (clinical study protocols/amendments, clinical study reports, investigator’s brochure), and sections of regulatory submissions.  As a key member of the Clinical Study Team, the Senior/Principal Medical Writer will have the opportunity to collaborate cross-functionally and ensure key messages are consistently aligned in the preparation of clinical regulatory documents.  

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 update reports (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.

Qualifications

  • Advanced degree (MS or PhD) in a relevant scientific field.
  • 3-5 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 experience strongly preferred.
  • Experience working in a fast-paced environment.

Job Location: Cambridge, MA

Please send resumes to talentacquisition@bostonbiomedical.com