Telecommute Senior Regulatory Medical Writer in San Francisco

Location: California

Compensation: Salary

Staff Reviewed: Thu, Jul 08, 2021

This job expires in: 8 days

Job Category: Writing

Remote Level: 100% Remote

Employer Type: Staffing Agency

Job Summary

A staffing agency is seeking a Telecommute Senior Regulatory Medical Writer in San Francisco.

Must be able to:

  • Author, co-author, critically edit, and format regulatory documents including protocols, CSRs, Investigator Brochures, briefing documents, NDAs, MAAs, INDs, IBs, and other regulatory submissions
  • Author, co-author, and critically edit publications including abstracts, amendments, protocols, manuscripts, and review articles
  • Support the development of medical writing processes, SOPs, work instructions, and document quality control

Applicants must meet the following qualifications:

  • Experience using the TransCelerate Common Protocol Template (CPT)
  • Demonstrated excellent writing skills coupled with knowledge of the drug development process and regulatory guidelines
  • Proven initiative and ability to handle a variety of projects simultaneously
  • Advanced knowledge of clinical and regulatory documents and publication practices including GCP, ICH, ICMJE, and CONSORT
  • Tech-savviness with the initiative and drive to support the implementation of software solutions to streamline medical writing processes
  • Ability ot maintain subject area expertise relating to the client's investigational products, disease indications, and regulatory and publication guidelines, phases of submission

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