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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
Consider reaching out to current or former employees of StudySmarter on platforms like LinkedIn. They can provide valuable insights into the company culture and expectations, which can help you tailor your approach during interviews.
✨Tip Number 4
Prepare for potential interview questions by practising how you would discuss your previous projects and experiences. Focus on your project management skills and how you've successfully collaborated with teams, as these are key aspects of the role.
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 experiences that demonstrate your ability to collaborate with teams and manage timelines effectively.
Showcase Your Communication Skills: Since excellent communication is crucial for this role, provide examples of how you've successfully articulated complex ideas to diverse audiences in your application. This could be through previous projects or presentations.
Highlight Continuous Improvement Initiatives: Discuss any contributions you've made towards improving writing standards or processes in your past roles. This shows your commitment to quality and aligns with the company's focus on continuous improvement.
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, highlighting your experience with clinical documents and regulatory submissions. Be prepared to discuss your writing process and how you ensure clarity and compliance.
✨Demonstrate Project Management Experience
This role requires strong project management skills. Be ready to share examples of how you've managed timelines, liaised with clients, and resolved conflicts in document reviews. Highlight any tools or methods you use to keep projects on track.
✨Understand Regulatory Requirements
Familiarise yourself with the latest EU and US regulatory guidelines relevant to the role. During the interview, demonstrate your knowledge of specific documents like Common Technical Documents and orphan drug designations. This shows your commitment to staying updated in the field.
✨Emphasise Collaboration Skills
The position involves working with cross-functional teams. Prepare to discuss how you've successfully collaborated with different stakeholders in the past. Share examples of how you’ve mentored junior writers or contributed to team improvements, aligning with the company's values.
