Medical / Regulatory Writer – US Timings

Experience: 2 – 10 years

Role:  Medical / Regulatory Writer

Industry: Medical

Employment Type: Full Time, Work from home

Job Description

  • All candidates must be fluent in spoken and written English (accents are okay as long as they speak great English)
  • All candidates must work during normal US business hours according to client needs.
  • All candidates must be available for full-time work (40 hours per week) Monday-Friday.

Mandatory Skills

  • PhD/PharmD in a scientific or medical discipline
  • Fluent in English (written and verbal)
  • 2+ years of experience in medical/regulatory writing
  • Clinical Study Report (CSR) CSRs
  • Pharmacovigilance writing
  • International experience desirable (EMA, TGA, PMDA)
  • Strong knowledge of FDA/ICH guidelines and GCP
  • Risk Management profiles, DSURs, IMPD, Pre-IND Briefing documents, Phase I, II, III protocols
  • Depth of industry and drug development knowledge
  • Expert in literature search techniques
  • Proficiency in Medical Terminology
  • Strong knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation
  • Superior working knowledge of software programs in Windows environment with excellent proficiency in word processing, flow diagrams, and spreadsheets
  • Ability to learn fast, grasp the ‘essence’ of a strategy or a story quickly to convert relevant scientific data/information into high quality summaries and reports
  • Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects and/or other writers simultaneously
  • Well-developed analytical skills and strong knowledge of medical terminology
  • Cross therapeutic experience across therapeutic areas and phases

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