Technical Documentation Specialist

2 weeks ago


City of London, United Kingdom Proclinical Staffing Full time
Job Summary
Proclinical is seeking a highly skilled Technical Documentation Specialist to join their team. This role requires a strong background in technical writing, regulatory compliance, and gene therapies. The successful candidate will be responsible for authoring and driving sections of the CMC dossier, ensuring timely and accurate quality submissions.

About Proclinical Staffing
We are a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Our team is dedicated to providing personalized service and exceeding client expectations.

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.

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.

Estimated Salary: $120,000 - $180,000 per year

This is a remote working position that offers a competitive salary and excellent benefits.

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