System One Services Medical Writer in Cambridge, Massachusetts

Medical WriterCambridge, Massachusetts

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Category:Scientific & Clinical

Job ID:126864

Date Posted:04/13/2018

Responsibilities for Medical Writer:

  • Responsible for authoring clinical and regulatory documents (e.g., study protocols, investigator brochures, clinical study reports, INDs, and BLA/MAAs) as well as clinical publications

  • Assume lead writing responsibility on all clinical development programs

  • Plan, prepare, write, edit, format, and finalize non-clinical, clinical and regulatory documents. Documents will include, but are not limited to: IND, CTA, non-clinical summaries, clinical protocols, clinical study reports, Investigator brochures, updates to regulatory submissions, briefing books, manuscripts and posters

  • Represent Medical Writing on project teams and, as such, advise teams on content and format requirements for various documents, as well as coordinate writing activities for document development

Requirements for Medical Writer:

  • BS Degree

  • 6+ years of medical writing experience in a pharmaceutical/biotechnology or CRO environment

  • Experience in oncology therapeutic areas

  • In-depth experience in US and European regulatory submissions

  • Ability to interpret and present clinical and non-clinical data objectively in a clear and concise format.

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