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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 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 train others during discussions. Highlight any previous experiences where you've guided junior writers or contributed to process improvements, as this aligns well with the responsibilities 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 managing timelines, collaborating with teams, and any specific projects that align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory writing and your understanding of the role. Mention specific experiences that demonstrate your ability to prepare clinical documents and manage projects effectively.
Highlight Relevant Qualifications: Clearly state your educational background, especially if you have a higher degree in life sciences. Include any certifications or training related to regulatory affairs or medical writing that could set you apart.
Showcase Communication Skills: Since excellent communication is key for this role, provide examples of how you've successfully engaged with clients or collaborated with cross-functional teams. This could be through specific projects or initiatives you've led.
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 during document reviews. Highlight any tools or methodologies 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
Collaboration is key in this position. Prepare to discuss how you've worked with cross-functional teams and external stakeholders in the past. Share examples of how you’ve contributed to team success and supported junior writers, showcasing your leadership potential.
