Remote Medical Writer

  • Charlottesville, VA
  • Direct Hire
  • Job ID: BN38-2692245

$1 to $2 Per Year

Remote Medical Writer for Pharmaceutical company. Must have Clinical writing and Submission experience

This position works to write scientifically valid, complete, and consistent documents, including but not limited to clinical study protocols, IND, IND amendments, regulatory responses  clinical study reports (CSRs), investigator's brochures (IBs), briefing books, and other similar items.

Key Responsibilities

  • Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
  • Write and edit clinical development documents, including but not limited to clinical protocols, investigators brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, presentation materials and publications to medical journals
  • Complete writing assignments in a timely manner
  • Maintain timelines  for multiple  assignments and workflow of writing assignments  meeting agreed timelines
  • Practice good internal and external customer service
  • Ability to work collaboratively with outside vendors
  • Highly proficient with styles of writing for various regulatory documents
  • Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
  • Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary



Knowledge, Skills and Experience

  • At least 5 years of previous experience in the pharmaceutical industry
  • Must have at least 3-5 years of industry regulatory writing and clinical medical writing    experience
  • The ideal candidate would hold a Bachelors or Masters, in scientific, medical, clinical discipline
  • Substantial  experience across all clinical documents and formats.
  • Experience leading and managing teams while authoring regulatory documents with aggressive timelines
  • Understanding of clinical data •
  • Exceptional writing skills are a must
  • Excellent organizational skills and the ability to multi-task are essential prerequisites
  • Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools


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