Technical Dossier Author and Strategist

2 weeks ago


London, Greater London, United Kingdom Proclinical Staffing Full time

**About the Role**

We are seeking a highly skilled CMC Technical Writer to join our team. As a remote worker, you will be responsible for authoring and driving sections of the CMC dossier, ensuring compliance with regulatory requirements.

 

**Responsibilities**

  • Develop and maintain CMC documentation in accordance with regulatory requirements.
  • Collaborate with cross-functional teams to develop responses to health authority inquiries.
  • Ensure accuracy and completeness of data for regulatory submissions.
  • Contribute to dossier strategy and product development plans.
  • Lead and supervise dossier authoring activities for early and late-stage projects.
  • Identify and implement business improvements within the functional organization.

 

**Requirements**

  • A 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.
  • Ability to work independently with limited guidance.
  • Excellent communication and team-working skills.

 

**Estimated Salary Range:** $130,000 - $190,000 per annum, depending on experience.



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