Life Sciences Content Creator

2 days ago


London, Greater London, United Kingdom Proclinical Staffing Full time

Are you a highly skilled Life Sciences Content Creator looking for a new challenge? We are seeking a talented individual to join our team at Proclinical Staffing

Job Description

The successful candidate will be responsible for authoring and driving sections of the CMC dossier, ensuring compliance with regulatory requirements, and supporting technical functions in developing responses to health authority inquiries.

This role involves working on complex projects and leading programs, while also contributing to dossier strategy and product development plans. You will have the opportunity to work independently with limited guidance and develop your skills in gene therapies, technical dossier writing, and development.

Responsibilities
  • Author and drive sections of the CMC dossier, ensuring compliance with regulatory requirements.
  • Support technical functions in developing responses to health authority inquiries.
  • Ensure completeness, accuracy, and compliance of data for regulatory submissions.
  • Contribute to dossier strategy and product development plans.
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.
  • Ability to work independently with limited guidance.
  • Excellent communication and team-working skills.

Our estimated salary for this position is approximately $180,000 - $250,000 per year, depending on location and experience.



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