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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 healthcare by improving medical writing standards and processes.
- 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 innovative projects.
The predicted salary is between 36000 - 60000 £ 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 or webinars where you can meet people who work in similar roles. This can help you gain insights into the job and potentially lead to referrals.
✨Tip Number 2
Familiarise yourself with the latest regulatory guidelines and trends in medical writing. Being knowledgeable about current practices will not only boost your confidence but also demonstrate your commitment to staying updated in the field.
✨Tip Number 3
Prepare for interviews by practising common questions related to regulatory writing. Think about specific examples from your past experience that showcase your skills in managing projects, collaborating with teams, and resolving conflicts.
✨Tip Number 4
Showcase your ability to mentor and guide junior writers during discussions. Highlighting your leadership skills can set you apart, as this role involves supporting and training team members.
We think you need these skills to ace Senior Regulatory Writer
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities of a Senior Regulatory Writer. Familiarise yourself with the types of documents you will be expected to prepare and the regulatory frameworks involved.
Tailor Your CV: Highlight your relevant experience in medical writing and regulatory affairs. Be specific about your previous roles, the types of documents you've worked on, and any direct client engagement you've had. Use keywords from the job description to align your CV with the role.
Craft a Compelling Cover Letter: In your cover letter, express your passion for medical writing and regulatory affairs. Mention how your skills and experiences align with the company's values, such as being supportive and strategic thinkers. Provide examples of how you've contributed to project management and quality control in past roles.
Proofread Your Application: Ensure that your application is free from grammatical errors and typos. As a writer, attention to detail is crucial. Consider asking a colleague or friend to review your application before submission to catch any mistakes you might have missed.
How to prepare for a job interview at Meet Life Sciences
✨Showcase Your Writing Skills
As a Senior Regulatory Writer, your writing skills are paramount. Bring samples of your previous work to the interview, highlighting your ability to create clear and concise regulatory documents. Be prepared to discuss your writing process and how you ensure quality in your work.
✨Demonstrate Project Management Experience
This role requires strong project management skills. Be ready to share specific examples of how you've managed timelines and liaised with clients in past projects. Discuss any tools or methods you use to keep projects on track and how you handle conflicting feedback.
✨Understand Regulatory Requirements
Familiarise yourself with the latest EU and US regulatory requirements relevant to the role. During the interview, demonstrate your knowledge of these regulations and how they impact medical writing. This shows that you're proactive and well-informed about the industry.
✨Emphasise Collaboration Skills
Collaboration is key in this position. Prepare to discuss how you've worked with cross-functional teams in the past. Highlight your ability to communicate effectively with diverse audiences and how you resolve conflicts or misunderstandings during collaborative projects.
