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For Companies At a Glance
- Tasks: Create and manage clinical documents while collaborating with teams and clients.
- Company: Join a pioneering company that values strategic thinking and problem-solving.
- Benefits: Enjoy a supportive work culture with opportunities for mentorship and professional growth.
- Why this job: Make an impact in the medical field while developing your writing skills and expertise.
- Qualifications: A B.Sc. in life sciences and 3-5 years of relevant experience are required.
- Other info: Stay updated on regulatory developments and contribute to process improvements.
The predicted salary is between 48000 - 72000 £ per year.
The Senior Regulatory and Medical Writer provides medical writing support across regulatory affairs, clinical operations, and medical affairs teams on various projects. The role involves collaboration with internal teams and direct client engagement for standalone medical writing projects.
Specific Responsibilities:
- Prepare clinical documents, including study protocols, amendments, clinical study reports, and investigator brochures/updates.
- Develop EU and US regulatory documents, such as Common Technical Document clinical summaries and overviews, scientific advice briefing documents, pediatric investigation/study plans, PRIME/Breakthrough Therapy applications, and orphan drug designation applications.
- Manage projects by creating and maintaining timelines and liaising with clients while demonstrating strong time management skills.
- Oversee the document review process, resolve unclear/conflicting comments, and lead comment resolution meetings with clients.
- Organize quality control (QC) reviews of documents and address feedback.
- Provide editorial support and formatting for documents authored by regulatory affairs and clinical operations teams.
- Conduct peer reviews of documents from internal teams.
- Offer guidance and training to junior medical writers and other team members.
- Assist in the development, implementation, and maintenance of medical writing process improvements, including style guides, templates, toolbars, and proofreading software, and provide relevant training.
- Ensure that regulatory filings for assigned projects are maintained.
- Support ongoing projects and business activities, including mentoring team members.
- Stay updated on regulatory and clinical developments.
General Responsibilities:
- Adhere to departmental guidelines and best practices.
- Contribute to the continuous improvement of medical writing standards and processes.
- Collaborate effectively with cross-functional teams and external stakeholders.
Company Values: Supportive, Strategic Thinkers and Problem Solvers, Respected, Pioneering, and Inspiring.
Qualifications & Experience:
- Minimum of a B.Sc. in a life sciences subject (a higher degree is advantageous).
- Approximately 3-5 years of relevant experience in a consultancy or equivalent environment.
- Excellent written and verbal communication skills with the ability to articulate ideas clearly and engage diverse audiences.
- Strong proficiency in Microsoft Office, particularly Word.
Reporting Line: Chief Medical Officer
Senior Regulatory Writer employer: Meet Life Sciences
Contact Detail:
Meet Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Writer
✨Tip Number 1
Network with professionals in the regulatory writing field. Attend industry conferences, webinars, or local meetups to connect with others who work in similar roles. This can help you gain insights into the job market and potentially lead to referrals.
✨Tip Number 2
Familiarise yourself with the latest regulatory guidelines and trends in both the EU and US markets. Being knowledgeable about current regulations will not only boost your confidence but also demonstrate your commitment to staying updated in this fast-paced field.
✨Tip Number 3
Showcase your project management skills by discussing any relevant experiences where you successfully managed timelines and liaised with clients. Highlighting these abilities during interviews can set you apart from other candidates.
✨Tip Number 4
Prepare for potential interview questions by practising how you would handle document review processes and comment resolution meetings. Being able to articulate your approach to these scenarios will demonstrate your expertise and problem-solving skills.
We think you need these skills to ace Senior Regulatory Writer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory writing and medical documentation. Emphasise your skills in preparing clinical documents and managing projects, as these are key responsibilities for the role.
Craft a Compelling Cover Letter: In your cover letter, express your passion for regulatory writing and how your background aligns with the company's values. Mention specific projects you've worked on that demonstrate your ability to collaborate with cross-functional teams.
Showcase Your Communication Skills: Since excellent written and verbal communication skills are crucial for this position, provide examples of how you've effectively articulated complex ideas in previous roles. This could be through presentations, reports, or client interactions.
Highlight Continuous Improvement Initiatives: Discuss any experience you have in developing or implementing process improvements in medical writing. This could include creating style guides or training materials, which will show your commitment to enhancing writing standards.
How to prepare for a job interview at Meet Life Sciences
✨Showcase Your Writing Skills
As a Senior Regulatory Writer, your writing ability is crucial. Bring samples of your previous work to the interview, and be prepared to discuss your writing process and how you ensure clarity and compliance in your documents.
✨Demonstrate Project Management Experience
Highlight your experience in managing timelines and liaising with clients. Be ready to share specific examples of how you've successfully handled multiple projects simultaneously while maintaining quality and meeting deadlines.
✨Familiarise Yourself with Regulatory Guidelines
Make sure you're up-to-date with the latest EU and US regulatory requirements. Discussing recent changes or challenges in the regulatory landscape can show your commitment to staying informed and your expertise in the field.
✨Emphasise Collaboration Skills
This role involves working closely with various teams. Prepare to talk about your experience collaborating with cross-functional teams and how you handle feedback and resolve conflicts during the document review process.
