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- Tasks: Create essential clinical documents and collaborate with teams on medical device projects.
- Company: Expanding medical device company focused on innovation and quality.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Why this job: Make a real difference in healthcare by contributing to vital clinical evaluations.
- Qualifications: Bachelor’s degree in science and experience in clinical evaluation report writing.
- Other info: Join a dynamic team and enhance your skills in a supportive environment.
The predicted salary is between 35000 - 45000 £ per year.
We are looking for a Medical Writer with experience in CER writing (clinical evaluation report) to join a group of expanding medical device companies.
Responsibilities:
- Develop and contribute to key clinical and regulatory documents, including Clinical Evaluation Plans/Reports (CEP/CER), Post-Market Clinical Follow-Up (PMCF) Plans/Reports, Post-Market Surveillance (PMS) documentation, and Summaries of Safety and Clinical Performance (SSCP).
- Conduct scientific literature reviews and produce reports (e.g. periodic safety updates, annual literature reviews) to support global regulatory submissions.
- Apply robust scientific methodologies to generate high-quality clinical evidence and documentation.
- Create and maintain SOPs, work instructions, and templates to ensure compliant clinical documentation processes.
- Collaborate cross-functionally to support product lifecycle activities, including risk management, vigilance, labelling, and promotional materials.
- Support regulatory submissions by addressing queries from notified bodies, auditors, and regulatory authorities.
- Contribute to issue resolution, CAPA activities, and continuous improvement initiatives.
- Work collaboratively within a cross-functional team environment, ensuring compliance with quality and safety standards.
Requirements:
- Bachelor’s degree in science.
- Excellent English communication skills.
- Experience with writing clinical evaluation reports for medical devices.
- Willingness to travel when needed.
- Candidates are required to be based in the UK and have the right to work in the UK.
Medical Writer employer: Kinetica
Contact Detail:
Kinetica Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Medical Writer
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical writing field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of clinical evaluation reports and regulatory submissions. We recommend practising common interview questions with a friend to boost your confidence and ensure you shine during the real deal.
✨Tip Number 3
Showcase your expertise! Create a portfolio of your previous work, especially any CERs or related documents you've written. This will give potential employers a taste of your skills and help you stand out from the crowd.
✨Tip Number 4
Don’t forget to apply through our website! We’re always on the lookout for talented individuals like you. Plus, it’s a great way to ensure your application gets the attention it deserves.
We think you need these skills to ace Medical Writer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Medical Writer role. Highlight your experience with clinical evaluation reports and any relevant projects you've worked on. We want to see how your skills match 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 background fits with our needs. Be sure to mention your experience with regulatory submissions and cross-functional collaboration.
Showcase Your Communication Skills: Since excellent English communication skills are a must, make sure your application is clear and concise. Avoid jargon unless it's necessary, and keep your language professional yet approachable. We love a good storyteller!
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’re considered for the role. Plus, it shows you’re keen to join our team!
How to prepare for a job interview at Kinetica
✨Know Your Stuff
Make sure you brush up on your knowledge of clinical evaluation reports and the specific requirements for medical devices. Familiarise yourself with the latest regulations and guidelines, as this will show your potential employer that you're serious about the role.
✨Showcase Your Writing Skills
Prepare samples of your previous work, especially any CERs or related documents you've written. Be ready to discuss your writing process and how you ensure clarity and compliance in your documentation. This is your chance to shine!
✨Be Ready for Technical Questions
Expect questions that dive deep into scientific methodologies and regulatory processes. Think about how you would approach a literature review or handle queries from regulatory bodies. Practising these scenarios can help you feel more confident during the interview.
✨Demonstrate Team Spirit
Since collaboration is key in this role, be prepared to talk about your experience working in cross-functional teams. Share examples of how you've contributed to team success and resolved issues together. This will highlight your ability to fit into their company culture.