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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 train others during discussions with potential employers. Highlight any 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 preparing clinical documents and managing projects, as these are key responsibilities for the role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your understanding of the role and the company’s values. Mention specific experiences that demonstrate your ability to collaborate with teams and manage timelines effectively.
Highlight Relevant Qualifications: Clearly state your educational background and any additional qualifications that relate to life sciences. If you have a higher degree or certifications in medical writing, make sure to include them prominently.
Showcase Communication Skills: Since excellent communication is crucial for this position, provide examples of how you've successfully articulated complex ideas to diverse audiences in your previous roles. This could be through presentations, reports, or client interactions.
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.
✨Demonstrate Project Management Experience
Highlight your experience in managing timelines and liaising with clients. Be ready to share specific examples of how you've successfully handled multiple projects simultaneously while maintaining quality and meeting deadlines.
✨Familiarise Yourself with Regulatory Guidelines
Make sure you are up-to-date with the latest EU and US regulatory requirements. Discussing recent changes or challenges in the regulatory landscape can show your commitment to staying informed and your expertise in the field.
✨Emphasise Collaboration Skills
This role involves working closely with cross-functional teams. Prepare to talk about your experiences collaborating with different stakeholders, resolving conflicts, and how you contribute to a supportive team environment.
