Role: Nonclinical Scientific Writer
Location: Remote or Hybrid
Hours: Full-time
Pay: £55.96 – £67.16 per hour PAYE basic excluding holiday pay or £75 – £90 per hour LTD/UMB
Contract: 12-month Contract, Outside IR35

An excellent opportunity has arisen for an experienced Nonclinical Scientific Writer to join a global pharmaceutical organisation within its Pharmaceutical Research and Early Development function.

This is a 12-month contract, outside IR35, supporting nonclinical regulatory submissions and scientific documentation activities. The successful candidate will work closely with scientific, regulatory and project stakeholders to prepare high-quality nonclinical documentation for Health Authority submissions across the drug development lifecycle.

This is a specialist writing role and would suit someone with proven experience preparing and reviewing nonclinical regulatory documents, CTD modules, toxicology/pharmacology summaries, study reports or submission-ready scientific documentation.

Benefits:

• 12-month contract outside IR35

• Remote or hybrid working options available

• Opportunity to work within a global pharmaceutical environment

• Exposure to early and late-stage drug development programmes

• Highly scientific and collaborative working environment

• Opportunity to contribute to regulatory submissions for innovative medicines

The Requirements:

• Degree in Life Sciences, Pharmaceutical Sciences, Toxicology, Pharmacology or a related scientific discipline

• Several years of experience in scientific writing, medical writing or regulatory writing within a nonclinical regulatory environment

• Direct experience preparing, reviewing or editing nonclinical regulatory submission documents

• Strong understanding of nonclinical development and regulatory documentation requirements

• Experience supporting IND, CTA, NDA, MAA, BLA or similar Health Authority submissions

• Familiarity with CTD structure, particularly nonclinical sections/modules

• Experience writing or reviewing toxicology, pharmacology, nonclinical summaries, study reports or research-related regulatory documents

• Strong understanding of ICH guidelines and regulatory writing standards

• Excellent written communication, editing and document quality skills

• Strong stakeholder management skills, with the ability to work closely with scientists, regulatory teams and project leaders

• Experience using scientific writing and document management software

• Proactive approach with strong attention to detail, accuracy and quality standards

The Role:

• Manage the preparation, review and submission of nonclinical regulatory documents

• Support documentation for early development and marketing applications

• Prepare and review nonclinical summaries, study reports and submission-ready scientific documents

• Collaborate with regulatory and scientific teams to ensure accurate, clear and compliant submissions

• Work closely with Nonclinical Project Leaders and Scientists to gather data, resolve queries and produce high-quality documentation

• Ensure documents are clearly written, scientifically accurate, consistent and aligned with internal and ICH standards

• Coordinate document review cycles, comments, approvals and submission timelines

• Support the development and maintenance of scientific writing processes, templates, tools and guidelines

• Contribute to regulatory initiatives, process improvements and technology projects

• Ensure all documentation is submission-ready and suitable for Health Authority review

This role would suit an experienced Nonclinical Scientific Writer, Regulatory Writer, Medical Writer, Toxicology Writer, Pharmacology Writer or Regulatory Documentation Specialist with a strong background in nonclinical regulatory documentation and pharmaceutical submissions.

Please note: this is not a general laboratory, QC, clinical pharmacy or entry-level Regulatory Affairs role. Candidates must be able to demonstrate hands-on experience in nonclinical regulatory scientific writing or closely related submission documentation.

If you're keen to join an exceptional scientific team offering global regulatory exposure, collaborative working and the opportunity to contribute to the development of innovative medicines, please apply to this Nonclinical Scientific Writer role below or call Chloe McCausland on between 8:30am – 5:00pm.