CMC Technical Writer

4 weeks ago

City Of London, United Kingdom Proclinical Staffing Full time

Proclinical is seeking a CMC Technical Writer to join the team. 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 position requires a high level of autonomy and accountability, with a focus on timely and accurate quality submissions. This is a remote working position.

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.
  • Lead and supervise dossier authoring activities for early and late-stage projects.
  • Identify and implement business improvements within the functional organization.
  • Interface with CMC/Tech team members, regulatory bodies, external service providers, and internal stakeholders.
  • Influence and persuade stakeholders to accept new ideas and approaches.
  • Manage several complex projects and lead complex programs.
  • Mentor and coach team members and project teams.

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.
  • Ability to work independently with limited guidance.
  • Excellent communication and team-working skills.
  • Experience in managing complex projects and leading programs.
  • Ability to identify and implement innovative approaches to improve products and processes.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com



Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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