Crafting compliant, high-impact regulatory documents that drive global drug development forward.
Proclinical is seeking a Regulatory Documentation Scientist to support the preparation and submission of nonclinical regulatory documents. This role focuses on ensuring high-quality, compliant documentation for regulatory submissions, including INDs, CTAs, NDAs, MAAs, and BLAs. You will collaborate with cross-functional teams to deliver accurate and impactful scientific content.
This position offers flexibility with remote or hybrid work options, empowering you to balance productivity and collaboration.
Responsibilities:
- Manage the preparation, review, and submission of nonclinical summary documents for early development and marketing applications.
- Collaborate with regulatory and scientific teams to ensure comprehensive and accurate nonclinical dossiers are submitted to health authorities.
- Work closely with Nonclinical Project Leaders and Scientists to draft regulatory submission documents, study reports, and other research-related materials.
- Develop and maintain processes, tools, and guidelines to ensure high-quality document production.
- Represent the nonclinical team in global regulatory initiatives and projects focused on process and technology improvements.
Key Skills and Requirements:
- A university degree in a life science discipline.
- Experience in scientific writing and editing within a nonclinical regulatory domain.
- Proficiency in writing and editing software, with an interest in exploring new tools and technologies.
- Strong collaboration and communication skills, with the ability to build trust and work effectively with diverse stakeholders.
- A commitment to producing high-quality, customer-focused documentation.
- Proactive problem-solving skills and a sense of ownership over your work.
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 applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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