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For Companies At a Glance
- 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
Network with professionals in the medical writing field. Attend industry conferences, webinars, or local meetups to connect with others who may have insights into the role and can provide referrals.
✨Tip Number 2
Familiarise yourself with the latest regulatory guidelines and trends in medical writing. This knowledge will not only enhance your understanding but also demonstrate your commitment to staying current in the field during interviews.
✨Tip Number 3
Prepare to discuss specific projects you've managed in the past. Highlight your experience in coordinating with cross-functional teams and how you ensured compliance and quality in your documentation.
✨Tip Number 4
Showcase your leadership skills by discussing any mentoring or training experiences you've had with junior writers. This will illustrate your ability to lead a team and contribute to their professional development.
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: Write a cover letter that showcases your passion for medical writing and your understanding of regulatory requirements. Mention specific examples of documents you have managed and how they contributed to successful project outcomes.
Highlight Collaboration Skills: In your application, emphasise your ability to work with cross-functional teams. Provide examples of how you've coordinated with various stakeholders to ensure project alignment and success.
Showcase Quality Control Experience: Detail your experience with quality control processes in your application. Discuss how you ensure accuracy and compliance in documentation, as well as any tools or methods you use to maintain high standards.
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 with cross-functional teams and met tight deadlines.
✨Demonstrate Regulatory Knowledge
Familiarise yourself with the relevant regulatory guidelines and standards. Be ready to explain how you've ensured compliance in your previous roles, particularly in the context of medical writing.
✨Prepare for Technical Questions
Expect questions about scientific and medical terminology, as well as clinical trial processes. Brush up on these topics to confidently answer any technical queries that may arise during the interview.
✨Emphasise Mentoring Experience
If you have experience mentoring junior writers, make sure to highlight this. Discuss how you've contributed to their development and the collaborative environment you've fostered within your team.
