CMC Technical Writer

Location Fort Collins, Colorado
Job type Permanent
Salary Negotiable
Contact Kyle Murfin
Job ref CMCTechKM_1560989815

Job description

Manager, CMC Technical Writer - Fort Collins, CO

An experienced technical Dossier (CTD) Development writer within R&D CMC (Chemistry, Manufacturing and Controls) to support the development of new and existing projects. This Dossier (CTD) Development person is responsible for the generation, ownership and oversight of the Module 3 (and M2 QoS) throughout its lifecycle from Phase 1 inception through to post approval lifecycle management. This person will work with functional teams in the preparation and review of CMC technical documents (including, but not limited to, formulation development/analytical protocols and reports, research proposals, summaries, INDs, NDAs, Annual Reports).


  • Manage the Dossier (CTD, IMPD, IND, NDA, ASMF and DMF) for Indivior R&D Fort Collins (FC) supporting global Module 3 development, including M2 QoS, covering Drug Substance and Drug Product development, for both internal and external (3rd party) developments
  • Lead M3 activities within the new and existing substance and product pipeline, ensuring the documentation of all technical aspects of the development are of the highest quality and with any issues highlighted to stakeholders in a timely manner.
  • Develop and maintain M3 documents from first phase IND/IMPD in accordance with global and regional regulatory best practise through to post approval lifecycle management


  • Bachelor's Degree in scientific discipline required.
  • Demonstrated CMC technical writing skills with at least 10 years of pharmaceutical industry experience in pharmaceutical manufacturing or development and regulatory submissions is required.
  • Proven track record of delivering high quality work to tight deadlines.

Manager, CMC Technical Writer - Fort Collins, CO

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