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CMC Regulatory Technical Writer

Salary undisclosed

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The Fountain Group are a national staffing firm and are currently seeking a CMC Regulatory Technical Writer for a prominent pharmaceutical client of ours. This position is Remote. Details for the position are as follows:

Job Description:

  • Pay: 40.00-53.00/hr.
  • Length of Assignment: 1 year with potential for extension or conversion.
  • Develops and authors chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post-approval regulatory dossiers within pre-established timelines.
  • Candidates must possess Chemistry, Manufacturing and Controls (CMC) and CTD authoring experience (Modules 2 and 3).
  • This includes responses to health authority inquiries, regulatory dossier amendments, supplements, variations, and annual reports.
  • Additionally, the technical writer authors and evaluates change controls for global regulatory impact, and is sometimes called upon to author technical reports, position papers, white papers, or SOPs.
  • Expertise with document management systems such as Veeva or Documentum is a plus.

The Fountain Group are a national staffing firm and are currently seeking a CMC Regulatory Technical Writer for a prominent pharmaceutical client of ours. This position is Remote. Details for the position are as follows:

Job Description:

  • Pay: 40.00-53.00/hr.
  • Length of Assignment: 1 year with potential for extension or conversion.
  • Develops and authors chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post-approval regulatory dossiers within pre-established timelines.
  • Candidates must possess Chemistry, Manufacturing and Controls (CMC) and CTD authoring experience (Modules 2 and 3).
  • This includes responses to health authority inquiries, regulatory dossier amendments, supplements, variations, and annual reports.
  • Additionally, the technical writer authors and evaluates change controls for global regulatory impact, and is sometimes called upon to author technical reports, position papers, white papers, or SOPs.
  • Expertise with document management systems such as Veeva or Documentum is a plus.