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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 project management skills and experience with document review processes. Be ready to share specific examples that highlight your ability to manage timelines and collaborate effectively.
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 medical writing and how your background aligns with the company's values. Mention specific experiences that demonstrate your ability to collaborate with cross-functional teams and manage timelines effectively.
Showcase Your Communication Skills: Since excellent written and verbal communication skills are crucial for this position, consider including examples of how you've successfully articulated complex ideas to diverse audiences in your application materials.
Highlight Continuous Improvement Initiatives: Discuss any past experiences where you contributed to improving writing standards or processes. This could include developing style guides or implementing new tools, which 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, and be prepared to discuss your writing process and how you ensure clarity and compliance in your documents.
✨Understand Regulatory Requirements
Familiarise yourself with the latest EU and US regulatory guidelines relevant to the role. Being able to discuss these regulations and how they impact your writing will demonstrate your expertise and commitment to the field.
✨Demonstrate Project Management Experience
Highlight your experience in managing timelines and liaising with clients. Be ready to provide examples of how you've successfully handled multiple projects and resolved conflicts during the document review process.
✨Emphasise Collaboration Skills
This role requires working closely with cross-functional teams. Prepare to discuss how you've collaborated with different stakeholders in the past, and share specific instances where your teamwork led to successful outcomes.
