Toxicology / Nonclinical Documentation Writer

Nonclinical Scientific Writer

Relevant Job Titles

• Nonclinical Scientific Writer / Nonclinical Regulatory Writer / Nonclinical Medical Writer / Preclinical Scientific Writer / Toxicology Documentation Specialist / Regulatory Submissions Writer (Nonclinical)

Location:
Welwyn Garden City (Hybrid or Remote)

Duration:
12 Months (Likely Extension)

Start Date:
January 2026

IR35:
Outside IR35

Right to Work:
Full UK RTW required (no sponsorship)

Role Overview

This role is ideal for an experienced
Nonclinical Scientific Writer
skilled in preparing high-quality regulatory documentation for global Health Authority submissions. You will lead, coordinate, and produce nonclinical scientific documents supporting applications such as
INDs, CTAs, NDAs, MAAs, and BLAs
.

You will ensure all documents are scientifically accurate, consistent, clearly written, compliant with
ICH guidelines
, and aligned with internal documentation standards. The position requires close collaboration with regulatory, toxicology, and scientific stakeholders across early development and research functions.

Key Responsibilities

• Manage the
  preparation, authoring, review, and submission
  of nonclinical summary documents for early development and marketing applications.
• Collaborate with cross-functional partners (e.g., Nonclinical Project Leaders, Scientists, Regulatory Affairs) to compile
  comprehensive, compliant nonclinical dossiers
  .
• Compose and edit regulatory submission documents, study reports, and research-related scientific content.
• Develop, maintain, and refine
  processes, templates, tools, and guidelines
  to enhance documentation quality and efficiency.
• Represent the nonclinical documentation function in
  global regulatory, process, and technology projects
  .
• Ensure all nonclinical documents adhere to
  ICH standards
  and internal quality expectations.

Essential Qualifications & Experience

• University degree in a
  life science discipline
  (e.g., biology, toxicology, pharmacology, biomedical sciences).
• Several years of hands-on experience in
  nonclinical scientific writing
  and editing within a regulatory environment.
• Proven experience preparing documents for
  Health Authority submissions
  (IND/CTA/NDA/MAA/BLA).
• Strong understanding of nonclinical development, regulatory requirements, and documentation standards.
• Expertise with writing and editing tools (e.g., MS Word, document management systems) and willingness to adopt new technologies.
• Ability to work effectively with diverse scientific and regulatory stakeholders and build trusted partnerships.
• Strong organisational skills, ownership mindset, and ability to proactively identify and resolve issues.

Preferred Experience

• Experience developing or improving
  documentation processes, standards, or tools
  within a pharma/biotech setting.
• Experience participating in
  global regulatory or technology-focused initiatives
  .
• Background within a
  large pharmaceutical or biotech
  environment, ideally early R&D.
• Familiarity with regulatory submission platforms and structured content management systems.
• Demonstrated interest in
  innovation, digital tools, and continuous improvement
  within scientific writing.

Ideal Candidate Profile

You are an experienced
nonclinical regulatory writer
who:

• Has deep familiarity with nonclinical data and Health Authority expectations.
• Enjoys working cross-functionally in a matrix environment.
• Produces clear, accurate, compliant scientific documents.
• Takes ownership of deliverables and ensures high-quality outputs.
• Values continuous improvement and embraces new tools or processes.

Candidate Profiles to Avoid

• Writers without direct
  nonclinical regulatory submission
  experience.
• Generalist medical writers, publications writers, or clinical writers without nonclinical expertise.
• Purely academic profiles with no industry regulatory documentation experience.
• Candidates lacking strong written communication skills or documentation accuracy.
• Individuals resistant to adopting new digital tools or document systems.

Pharmaceutical | Biotechnology | Early Development | pRED | Nonclinical | Preclinical | Toxicology | IND | CTA | NDA | MAA | BLA | ICH Guidelines | Regulatory Submissions | Scientific Writing | Document Management | Regulatory Affairs | Health Authority Dossiers