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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 🫡
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 or led discussions in previous roles.
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 junior writers, 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 skills are paramount. Bring samples of your previous work to the interview, highlighting your ability to create clear and concise clinical 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 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 EU and US regulatory documents relevant to the position. During the interview, demonstrate your knowledge of these requirements and how they impact the writing process. This will show that you are proactive and well-prepared for the role.
✨Emphasise Collaboration Skills
Collaboration is key in this role, so be prepared to discuss your experience working with cross-functional teams. Share specific examples of how you've successfully collaborated with others, resolved conflicts, and contributed to team success in previous roles.
