Medical Writer (FT, Princeton)

Job Title:
Medical Writer

Full time, Princeton, NJ

Job Description:
Medical Writer
Reports to Director of Clinical Research

Position Summary:
Responsible for:

  • Writing and reviewing clinical study-related documents (e.g., protocols, clinical study reports, investigator brochures)
  • Review and analysis of study data, and interpretation and summarization of the study results
  • Scientific expertise in order to contribute to protocol development and data interpretation

Estimated Time Allocation:

  • Prepare clinical protocols, Investigator brochures and supplements these documents (draft outlines and write protocols; coordinate review meetings; prepare amendments as needed, finalize and version-control
    documents) 30%
  • Coordinate, review and revise clinical study reports (critically review CSRs for accuracy, adherence to the protocol, and overall content; coordinate inter-departmental reviews; compile information for appendices) 25%
  • Search and review literature sources in order to contribute to study designs and data interpretation (focusing on therapeutic areas, biomarkers, methodology, trial designs/results, competitors’ products), and summarize/present findings 10%
  • Prepare and review clinical and non-clinical data summaries for regulatory submissions (investigators brochures and supplements, as well as INDs and annual reports) 15%
  • Review data listings, TLFs, and prepare top line data presentations as needed 10%
  • Review trial-related documents from other departments (case report forms, statistical analysis plans, informed consent forms) 5%
  • Participate in SOP committee meetings, and update/create clinical research SOPs as needed 5%
  • Additionally, performs other duties as required and assumes other responsibilities as assigned by the supervisor/manager.

Experience Needed:

  • Minimum of 2 years (10 with a BS) of experience writing and reviewing clinical trial-related documents within the pharmaceutical industry
  • Strong scientific background and medical writing skills; knowledge of GLPs, GCPs, ICH guidelines and requirements for the successful conduct of clinical trials; strong computer skills
  • Must have strong oral and written communication skills and ability to work well in inter-departmental groups
  • Graduate degree in a science/life sciences discipline or equivalent/related education or BS with extensive experience
  • The work is performed in an office environment most of the time.
  • Travel is required on an as-needed basis (e.g., for training, site visits and meetings).

Contact: Laura Walton;

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