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- Tasks: Lead the creation of regulatory documents and collaborate with cross-functional teams.
- Company: Apsida Life Science, a specialist consulting firm in life sciences.
- Benefits: Competitive salary, impactful work, and a great work-life balance.
- Why this job: Make a real difference in healthcare by authoring critical regulatory documents.
- Qualifications: Advanced degree and 5+ years of medical writing experience required.
- Other info: Fully remote position with opportunities for professional growth.
The predicted salary is between 36000 - 60000 £ per year.
Apsida Life Science has partnered with a strategic firm that is a specialised cross-functional consulting firm supporting companies in the life science and healthcare sectors. They provide strategic and operational expertise across the product lifecycle, focusing on regulatory affairs, quality assurance, market access, and commercial strategy.
The Opportunity:
- Regulatory Dossier Authoring.
- Lead the planning, authoring, editing, and finalization of Common Technical Document (CTD) modules 2, 4, and 5 (Quality, Nonclinical, and Clinical Summaries and Reports) for regulatory submissions (e.g., NDA/BLA, MAA).
- Ensure all regulatory documents adhere to current regulatory guidance (e.g., ICH, FDA, EMA) and company standards.
- Collaborate cross-functionally with Clinical Development, Biostatistics, Regulatory Affairs, and Pharmacovigilance teams to source, interpret, and integrate data into documents.
- Author and finalize briefing books and related documentation for scientific advice meetings (e.g., FDA, EMA, national health authorities) to support development programs and address regulatory questions.
- Develop, author, and maintain Risk Management Plans (RMPs) in alignment with regulatory requirements and the company’s pharmacovigilance strategy.
General Medical Writing.
- Manage the document lifecycle, including version control, comment resolution, and final sign-off.
Qualifications:
- Advanced degree (PhD, Pharm.D., M.D., or Master's) in a relevant life sciences discipline.
- Minimum of 5+ years of experience as a Medical Writer in the pharmaceutical, biotechnology, or CRO industry.
- Extensive, proven experience in writing briefing books for scientific advice meetings.
- Expertise in authoring Risk Management Plans (RMPs).
- Direct experience with authoring and compiling regulatory documents for CTD Modules 2, 4, and 5.
What You Will Get:
- Competitive salary
- Impactful work
- Work-life balance
If you are interested in learning more, please reach out to Linda Goba at Apsida Life Science: Linda.goba@apsida.com
www.apsida.co.uk
+44 (0) 744 134 2145
Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best.
Medical Writer in Bristol employer: Apsida Life Science
Contact Detail:
Apsida Life Science Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Medical Writer in Bristol
✨Tip Number 1
Network like a pro! Reach out to professionals in the life sciences and healthcare sectors on LinkedIn. Join relevant groups, participate in discussions, and don’t be shy about asking for informational interviews. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for those interviews! Research the company and its projects thoroughly. Be ready to discuss how your experience aligns with their needs, especially around regulatory submissions and medical writing. We want you to shine, so practice common interview questions and have your own questions ready!
✨Tip Number 3
Showcase your expertise! Create a portfolio of your best work, especially any regulatory documents or briefing books you've authored. This will give potential employers a taste of your skills. We recommend having this ready to share during interviews or networking events.
✨Tip Number 4
Apply through our website! It’s the easiest way to get your application noticed. Plus, we’re always on the lookout for talented individuals like you. Don’t forget to follow up after applying; a little nudge can go a long way in showing your enthusiasm!
We think you need these skills to ace Medical Writer in Bristol
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Medical Writer role. Highlight your experience with regulatory documents and any specific projects that align with the job description. We want to see how your background fits perfectly with what we’re looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about medical writing and how your skills can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Relevant Experience: When detailing your experience, focus on your work with CTD modules and briefing books. We’re keen to see examples of your expertise in authoring Risk Management Plans and collaborating with cross-functional teams. Make it easy for us to see your strengths!
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. Plus, it shows you’re serious about joining our team!
How to prepare for a job interview at Apsida Life Science
✨Know Your Regulatory Stuff
Make sure you brush up on the latest ICH, FDA, and EMA guidelines. Being able to discuss these regulations confidently will show that you're not just familiar with them but can apply them in your writing.
✨Showcase Your Writing Skills
Prepare samples of your previous work, especially any briefing books or regulatory documents you've authored. This will give the interviewers a clear idea of your writing style and expertise in creating CTD modules.
✨Collaborative Spirit
Highlight your experience working cross-functionally with teams like Clinical Development and Biostatistics. Be ready to share examples of how you’ve successfully collaborated to integrate complex data into your documents.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s approach to regulatory submissions and their expectations for the role. This shows your genuine interest and helps you assess if it’s the right fit for you.