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CMC Technical Writer

Regulatory CMC Specialist/Technical Writer

An Oncology-focused biopharmaceutical corporation based on the East Coast is seeking to hire a Regulatory CMC Technical Writer for a contract running through 2018. This company commits to being a vital contributor to the cancer community by providing innovative therapies world-wide.

The Regulatory CMC Specialist/Technical Writer is responsible for: 1) Establish strategies for document authoring. 2) Develop technical writing time-lines & develop and lead the execution of regulatory CMC submission plans. 3) Determine authoring resource needs. 4) Coordinate authoring, review and approval of submission-ready documents as well as CTD sections for submissions. 5) Serve as the primary author and lead writer for CMC documents. 6) Ensure key messages are clear and consistent within and across documents, and ensure the vocabulary is consistent throughout the submission.

Location: Greater Lexington/Waltham, Massachusetts area

Duration: 6-month contract (renewable opportunities available)

Compensation: Negotiable hourly rate

Requirements:

  • Education: B.S. in a scientific or technical discipline.
  • 5-8+ (flexible) years of experience in biotech/pharma within Regulatory Affairs CMC or related.
  • Experience with small molecules and biologic new molecular entities is required.
  • Extensive experience in the organization and format of ICH CTD M3
  • Demonstrated ability for concise and precise technical writing for submissions, aligned with the principles of ICH Q12 and Established Conditions guidance
  • Experience writing QOS and Health Authority Query responses
  • Knowledge of drug development life-cycle, and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance
  • Excellent project management skills - ability to adapt to a product development environment and track diverse project deliverables
  • Strong expertise with Microsoft Word, proficiency with Microsoft Excel, Project and PowerPoint
  • Biologics experience is mandatory; small molecules is a plus
  • Post-Approval experience is mandatory

Sthree US is acting as an Employment Business in relation to this vacancy.