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- Tasks: Lead medical writing projects, ensuring high-quality regulatory documents and collaboration with diverse teams.
- Company: Join a dynamic pharmaceutical company focused on innovative healthcare solutions.
- Benefits: Enjoy flexible working options, professional development opportunities, and a supportive team culture.
- Why this job: Make a real impact in healthcare while developing your skills in a fast-paced environment.
- Qualifications: 5-8 years in medical writing, a relevant degree, and strong project management skills required.
- Other info: Opportunity to mentor junior writers and contribute to process improvements with AI tools.
The predicted salary is between 43200 - 72000 £ per year.
We are seeking an experienced Medical Writing Manager / Lead to oversee the planning, coordination, and delivery of key regulatory and scientific documents. The role involves collaboration with cross-functional teams, management of multiple projects, and a focus on delivering high-quality, compliant documentation.
Main Responsibilities
- Oversee the end-to-end management of medical writing projects, including planning, timeline management, stakeholder coordination, and delivery of final documents.
- Lead the development of a range of documents, including protocol outlines, informed consent forms, clinical study reports, sections of Module 2 of the eCTD, patient-facing materials, lay summaries, registry content, publications, posters, and abstracts.
- Ensure all content is scientifically accurate, clear, and consistent, meeting regulatory and internal quality standards.
- Coordinate with internal teams (clinical, regulatory, biostatistics, data management, patient engagement, project management) and external partners (CROs, KOLs, patient advocacy groups) to gather input and ensure alignment on objectives.
- Conduct quality control checks for accuracy, grammar, formatting, and template compliance across all documents.
- Ensure all documentation complies with applicable regulatory guidelines and company SOPs, and support submission readiness.
- Contribute to process improvement initiatives, including the implementation of AI tools and digital repositories to enhance document development efficiency.
- Maintain accurate records of timelines, milestones, and deliverables, providing regular progress updates to stakeholders.
- Support training and mentoring of junior writers, promoting collaboration and continuous learning within the team.
Requirements
- 5–8 years of medical writing and project management experience in the pharmaceutical, biotech, or related industry.
- Proven experience in a senior or principal medical writing role.
- Bachelor\’s degree in life sciences, pharmacy, or a related field; an advanced degree (e.g. MSc, PhD) is preferred.
- Fluency in English (spoken and written).
- Strong knowledge of scientific and medical terminology, regulatory guidelines, and clinical trial processes.
- Excellent project management, organizational, and communication skills.
- Ability to work independently and collaboratively in a fast-paced, deadline-driven environment.
- Experience mentoring junior team members is a plus.
Manager Medical Writing employer: Meet Life Sciences
Contact Detail:
Meet Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager Medical Writing
✨Tip Number 1
Familiarise yourself with the latest regulatory guidelines and standards in medical writing. This knowledge will not only help you during interviews but also demonstrate your commitment to maintaining high-quality documentation.
✨Tip Number 2
Network with professionals in the pharmaceutical and biotech industries. Attend relevant conferences or webinars where you can meet potential colleagues and learn about the latest trends in medical writing.
✨Tip Number 3
Prepare to discuss specific projects you've managed in the past, focusing on your role in coordinating teams and ensuring compliance. Highlighting your project management skills will be crucial for this managerial position.
✨Tip Number 4
Showcase your mentoring experience by preparing examples of how you've supported junior writers. This will illustrate your leadership capabilities and your commitment to fostering a collaborative team environment.
We think you need these skills to ace Manager Medical Writing
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in medical writing and project management. Emphasise your leadership roles and any specific projects that align with the responsibilities outlined in the job description.
Craft a Compelling Cover Letter: In your cover letter, address how your background meets the requirements of the role. Discuss your experience with regulatory documents and your ability to manage multiple projects while ensuring high-quality outputs.
Showcase Your Collaboration Skills: Provide examples in your application of how you've successfully collaborated with cross-functional teams. Highlight any experience working with external partners, as this is crucial for the role.
Demonstrate Your Knowledge: Include specific examples of your familiarity with regulatory guidelines and clinical trial processes. Mention any tools or methodologies you’ve used to improve document development efficiency, especially if they relate to AI or digital repositories.
How to prepare for a job interview at Meet Life Sciences
✨Showcase Your Project Management Skills
Be prepared to discuss your experience in managing multiple medical writing projects. Highlight specific examples where you successfully coordinated timelines and collaborated with cross-functional teams to deliver high-quality documents.
✨Demonstrate Your Knowledge of Regulatory Guidelines
Familiarise yourself with the relevant regulatory guidelines and standards for medical writing. During the interview, be ready to explain how you ensure compliance and quality in your documentation, as this is crucial for the role.
✨Prepare for Technical Questions
Expect questions related to scientific and medical terminology, as well as clinical trial processes. Brush up on these topics and be ready to discuss how you apply this knowledge in your writing and project management.
✨Emphasise Mentoring Experience
If you have experience mentoring junior writers, make sure to highlight this during the interview. Discuss how you promote collaboration and continuous learning within your team, as this aligns with the company's focus on team development.