At a Glance
- Tasks: Write and edit regulatory documents for major pharmaceutical clients in a fully remote role.
- Company: Join a fast-growing Regulatory Affairs consultancy with top-tier clients.
- Benefits: Flexible remote work, competitive pay, and the chance to impact global health.
- Other info: Ideal for those seeking a dynamic, fully remote work environment.
- Why this job: Make a difference in healthcare by ensuring compliance and accuracy in vital documents.
- Qualifications: Experience in medical writing and knowledge of ICH guidelines required.
We are seeking an experienced Medical Writer with strong regulatory expertise to support a rapidly growing Regulatory Affairs consultancy. They count some of the biggest multinational pharmaceutical companies as clients and continue to provide regulatory solutions that drive success. This is a fully remote, UK-based contract opportunity (outside IR35), ideal for a consultant with a proven track record in regulatory submission documents.
Your new role:
- Author, review, and edit regulatory documents in line with global submission requirements.
- Update existing documents: Clinical Overview (Module 2.5) and Clinical Summary (Module 2.7) documents.
- Collaborate cross-functionally with clinical, regulatory, and biostatistics teams.
- Ensure consistency, scientific accuracy, and compliance with ICH guidelines.
- Manage document timelines and incorporate feedback from multiple stakeholders.
- Support preparation for regulatory submissions (e.g. CTD/eCTD).
What you'll need to succeed:
- Several years' experience in medical writing within the pharmaceutical or biotech industry.
- Demonstrable expertise in Modules 2.5 and 2.7 (Clinical Overview and Clinical Summary).
- Strong knowledge of ICH guidelines and CTD structure.
- Proven ability to deliver high-quality documents to tight timelines.
- Excellent written and verbal communication skills.
- Must be UK-based with right to work.
- Experience supporting major regulatory submissions (EMA, MHRA, FDA).
- Experience working in a fully remote, cross-functional environment.
If you are an experienced Medical Writer with strong expertise in Modules 2.5 and 2.7 and are available for your next contract, I’d love to hear from you. Click 'apply now' to forward an up-to-date copy of your CV.
Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and must be based in the UK.
Medical Writer (Regulatory) in City of London employer: Hays Life Sciences
Join a dynamic Regulatory Affairs consultancy that champions innovation and excellence in the pharmaceutical sector. As a fully remote employer, we offer a flexible work culture that prioritises collaboration and professional growth, providing you with the opportunity to work alongside industry leaders on impactful regulatory submissions. With a commitment to employee development and a supportive environment, we ensure that your expertise as a Medical Writer is not only valued but also nurtured.
StudySmarter Expert Advice🤫
We think this is how you could land Medical Writer (Regulatory) in City of London
✨Network like a Pro
In the pharmaceutical industry, getting your foot in the door can often come down to who you know. So, connect with professionals through platforms like LinkedIn or attend industry-specific conferences and trade shows. These are golden opportunities to meet decision-makers and to showcase your expertise.
✨Show Off Your Expertise
As a freelancer, you really want to establish yourself as a go-to expert in your niche. Consider setting up a blog or contributing to pharmaceutical forums where you can share insights about trends and innovations. This will help increase your visibility and build credibility in the industry.
✨Join Freelance Platforms
Don't underestimate the power of freelance platforms that focus on the pharmaceutical sector. Websites like Upwork or industry-specific job boards can help you find gigs that match your skill set. Remember to tailor your profile to highlight your relevant experiences and credentials.
✨Leverage Your Local Networks
Since the pharmaceutical industry often hinges on relationships, reaching out to local universities or research institutions can lead to lead generation. They might have collaborations or projects looking for freelance talent. Plus, don’t forget to connect with local pharma associations for gigs and networking opportunities!
We think you need these skills to ace Medical Writer (Regulatory) in City of London
Some tips for your application 🫡
Showcase Your Expertise:In the pharmaceutical industry, it's super important to highlight your specific expertise. Make sure your CV or portfolio reflects your relevant experience—think clinical research, regulatory affairs, or drug development. Don’t forget to include any certifications or training you've completed that are particularly relevant to the role.
Include Case Studies or Project Samples:As a freelancer, your portfolio is your calling card. Include detailed case studies or samples from previous projects that highlight your contributions and results in the pharmaceutical sector. This could be anything from successful clinical trials you've worked on to regulatory submissions—use this to demonstrate your impact.
Articulate Your Availability and Rates:Freelance roles mean flexibility, so clarify your availability upfront. Be transparent about your rates too—this helps set the stage for negotiations. You can mention your preferred working hours and project lengths to align with what Hays Life Sciences might be looking for.
Tailor Your Cover Letter:Your cover letter should connect the dots between your experience and the needs of Hays Life Sciences. Use it to explain why you're interested in this freelance role specifically and how your background in the pharmaceutical industry can help solve their unique challenges. Let your personality shine through while remaining focused on professional achievements!
How to prepare for a job interview at Hays Life Sciences
✨Show Off Your Expertise
Freelancing in the pharmaceutical industry means you'll want to highlight your specialised knowledge. Make sure to showcase your experience with regulatory processes or clinical trials, as these are crucial in this field. Share specific projects you've worked on to demonstrate your capability!
✨Know Your Tools and Tech
If you've worked with any industry-specific software, like LabArchives or Empower, get ready to discuss your experience with them. Being familiar with these tools will set you apart during the interview, as they’re often central to project success in pharmaceuticals. Don’t forget to mention how you’ve used data analysis in your previous roles – it’s key in this sector!
✨Bring Your Portfolio to Life
As a freelancer, your portfolio is your calling card. Prepare a compelling presentation that outlines your previous projects, focusing on results and methodologies. Highlight any case studies or publications to show your contributions to research or development – this can really grab the attention of Hays Life Sciences.
✨Prepare for Scenario-Based Questions
Expect some scenario-based questions that might challenge your problem-solving skills in real-world contexts. Be ready to discuss how you would handle tight deadlines, regulatory hurdles, or unexpected findings in your projects. This will allow you to demonstrate not just your knowledge, but your practical abilities too!
