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For Companies At a Glance
- Tasks: Create high-quality regulatory documents for global Health Authority submissions.
- Company: Join a leading pharmaceutical company with a focus on innovation.
- Benefits: Hybrid or remote work, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in the medical field by ensuring compliance and accuracy in documentation.
- Qualifications: Experience in nonclinical scientific writing and regulatory submissions is essential.
- Other info: Collaborative environment with a strong emphasis on continuous improvement and innovation.
The predicted salary is between 36000 - 60000 £ per year.
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
- 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
- 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.
Job Details
- Seniority level: Associate
- Employment type: Full-time
- Job function: Writing/Editing, Research, and Science
- Industries: Medical Practices, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
Toxicology / Nonclinical Documentation Writer employer: Unity Systems
Contact Detail:
Unity Systems Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Toxicology / Nonclinical Documentation Writer
✨Tip Number 1
Network like a pro! Reach out to professionals in the toxicology and nonclinical writing fields on LinkedIn. Join relevant groups and participate in discussions to get your name out there and show off your expertise.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory submissions. Be ready to discuss your experience with INDs, CTAs, and other key documents. We want you to shine and show how you can contribute to the team!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you and tailor your approach to each application. We’re here to help you land that dream job!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Share any additional thoughts or insights you have about the role, showing your enthusiasm and commitment to the position.
We think you need these skills to ace Toxicology / Nonclinical Documentation Writer
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Toxicology / Nonclinical Documentation Writer role. Highlight your experience with regulatory submissions and nonclinical scientific writing, as this will show us you’re a perfect fit for the job.
Showcase Your Skills: Don’t forget to emphasise your expertise with writing and editing tools like MS Word. We want to see how you’ve used these skills in past roles, especially in preparing documents for Health Authority submissions.
Be Clear and Concise: When writing your application, keep it clear and to the point. We appreciate well-structured documents that are easy to read, so make sure your application reflects that quality.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates regarding the role.
How to prepare for a job interview at Unity Systems
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory submissions like INDs, CTAs, and NDAs. Being able to discuss these confidently will show that you understand the core of the role and can hit the ground running.
✨Showcase Your Writing Skills
Prepare samples of your previous nonclinical scientific writing. Highlight documents that demonstrate your ability to produce clear, compliant, and scientifically accurate content. This will give the interviewers a tangible sense of your capabilities.
✨Collaborate Like a Pro
Since this role involves working with various stakeholders, be ready to discuss your experience in cross-functional collaboration. Share specific examples of how you've successfully worked with scientists and regulatory teams to produce high-quality documentation.
✨Embrace Continuous Improvement
Talk about any processes or tools you've developed or improved in your past roles. Show that you're not just about maintaining standards but also about innovating and enhancing documentation quality, which is key in a fast-paced environment.
