CMC Technical Writer Specialist

5 days ago


London, Greater London, United Kingdom Proclinical Staffing Full time
Proclinical Staffing

We are seeking a highly skilled CMC Technical Writer to join our team. This role offers an exceptional opportunity to utilize your expertise in authoring and driving sections of the CMC dossier, ensuring compliance with regulatory requirements.

About the Role
  • Author and drive sections of the CMC dossier, ensuring compliance with regulatory requirements.
  • Support technical functions in developing responses to health authority inquiries.

This is a remote working position that requires a high level of autonomy and accountability, with a focus on timely and accurate quality submissions.

Key Skills and Requirements
  • PhD alongside post-doc experience and relevant years of working experience OR University degree with proven years of relevant experience.
  • Recent BLA experience for recombinant proteins is a necessity.
  • Strong background in gene therapies, technical dossier writing, and development.

The estimated salary range for this position is $90,000 - $120,000 per annum, based on industry standards and location. Proclinical Staffing offers a comprehensive benefits package, including competitive compensation, opportunities for professional growth, and a dynamic work environment.



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