Job Description

Transform complex science into clear regulatory narratives-join us as a Non-Clinical Scientific Writer.
R&D Partners is seeking NCSW to manage the submission of nonclinical documents to regulatory agencies in support of applications such as INDs, CTAs, NDAs, MAAs, and BLAs. This role requires strong scientific writing capabilities to ensure documents are clearly written, accurate, consistent, and adhere to ICH standards.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:

• Manage the preparation, review, and submission of nonclinical summary documents for early development and marketing applications.
• Collaborate with regulatory and scientific functions to ensure comprehensive and accurate nonclinical dossiers are submitted to Health Authorities.
• Work closely with Nonclinical Project Leaders and Scientists to compose regulatory submission documents, study reports, and other research-related materials.
• Develop and maintain processes, tools, and guidelines to enable high-quality document production.
• Represent the nonclinical team in global regulatory initiatives and projects focused on process and technology development.

Key Skills and Requirements:

• University degree in a life science discipline.
• Several years of experience in scientific writing and editing within a nonclinical regulatory domain.
• Proficiency in writing and editing software, with an interest in exploring and integrating new tools and technologies.
• Strong interpersonal skills to build trust and collaborate with diverse stakeholders.
• High attention to detail and commitment to producing high-quality documentation.
• Proactive approach to problem-solving and ownership of responsibilities.

For more information, please contact Mandi Cakwe.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.
R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.
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Skills Required