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- Tasks: Lead global medical writing for innovative treatments in a remote role with quarterly office visits.
- Company: Join a growing specialty pharmaceutical company focused on groundbreaking therapies for tough diseases.
- Benefits: Enjoy a competitive salary, car allowance, bonus, and flexible remote work options.
- Why this job: Be part of a mission-driven team making a real impact in healthcare with exciting projects.
- Qualifications: 10 years of relevant experience in regulatory medical writing; advanced degrees preferred.
- Other info: Must have the right to work in the UK; no sponsorship available.
The predicted salary is between 48000 - 72000 £ per year.
Senior Manager, Regulatory Medical Writing
Senior Manager, Regulatory Medical Writing
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Direct message the job poster from Cpl Life Sciences
Managing Consultant @ Cpl Life Sciences | Life Sciences Specialist /Regulatory Affairs & Quality
Job Role: Senior Manager, Regulatory Medical Writing
Job Type: Full-time, permanent.
Job Location: UK, Remote – Travel 1x a quarter to the office in Surrey.
Remuneration: £56,000 – £75,000 plus car allowance and bonus.
An opportunity to join a growing specialty pharmaceutical company that focuses on developing innovative treatments for hard-to-treat diseases, with key areas including immuno-oncology, gene therapy, mitochondrial biology, blindness and regeneration, and targeted protein degradation.
Acts as a Global Medical Writing Lead, generally in mid- to late-stage development global project teams. The individual provides leadership with respect to all program documents and may act as the departmental expert on IND/IMPD dossier components, briefing documents, and responses to regulatory authorities across programs.
The individual independently analyzes proposed program, study, and related documents for their ability to deliver the information required by the target audience (e.g., regulatory authority) with accuracy and consistency. The individual reviews documents within a therapeutic area with respect to consistency with the team/corporate established strategy and document history; ensures a consistent pattern of successful completion of assigned responsibilities within a program resulting in the production of high-quality documents that meet corporate needs and global regulatory requirements; and provides intellectual leadership and contributes document knowledge and expertise to the global project team.
Responsibilities:
- Acts as a primary lead for all assigned programs (generally mid- to late-stage development).
- As a document specialist, provides intellectual leadership and contributes document knowledge and expertise to the global project team.
- May act as the departmental expert on IND/IMPD dossier components, briefing documents, and responses to regulatory authorities across programs.
- Reviews documents within a therapeutic area with respect to consistency with the team/corporate established strategy and document history, ensuring a consistent pattern of successful completion of assigned responsibilities resulting in the production of high-quality documents that meet corporate needs and global regulatory requirements.
- For all documents within a program, independently implements adjustments in specific document content within framework of provided templates in order to fit the needs of specific document/core team requirements.
- Participates in standards and processes initiatives/activities and other departmental project activities (up to a total of 15% of time).
- May participate in a multidiscipline productivity or process initiative.
- Supports Line Management in the improvement of departmental performance and outsourcing alliances through analysis and evaluation of metrics and performance data.
Required Qualifications:
- BA/BS degree or equivalent, 10+ years relevant experience. Preferred: PhD/Pharm D or MS/MA/MPH with at least 10 years as a writing professional in the pharmaceutical industry, with 2-5 years\’ experience in managing/supervising activities associated with the creation of regulated documents in the pharmaceutical industry.
- Technical expert on all document types produced by medical writing.
- Demonstrated and substantial experience in leading/managing the creation of IND/IMPD and NDA/MAA components, briefing documents, and responses to regulatory authorities. Preferred experience in preparing for advisory committees.
- Strong communication and leadership skills; strategic thinker.
Please note this role is a senior role within the business, so you MUST have extensive experience in RA medical writing and have excellent communication skills.
The role DOES NOT offer job sponsorship, so you must hold the full right to work in the UK and be based in the United Kingdom.
For more information please reach out to me at lucy.kirkaldy@cpl.com
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Science and Writing/Editing
-
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Senior Manager, Regulatory Medical Writing employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager, Regulatory Medical Writing
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those involved in regulatory medical writing. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends in the field.
✨Tip Number 2
Showcase your leadership skills by discussing any previous experience managing teams or projects. Highlight specific examples where you led the creation of regulatory documents or improved processes within a team.
✨Tip Number 3
Familiarise yourself with the latest regulations and guidelines related to IND/IMPD and NDA/MAA submissions. Being well-versed in these areas will demonstrate your expertise and commitment to staying current in the field.
✨Tip Number 4
Prepare to discuss your strategic thinking abilities during interviews. Be ready to provide examples of how you've contributed to the success of past projects through innovative document strategies or by addressing challenges effectively.
We think you need these skills to ace Senior Manager, Regulatory Medical Writing
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive experience in regulatory medical writing. Focus on your leadership roles and specific projects that align with the job description, particularly those involving IND/IMPD and NDA/MAA components.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the pharmaceutical industry and your expertise in medical writing. Mention your strategic thinking and communication skills, and how they will contribute to the company's goals.
Highlight Relevant Experience: In your application, emphasise your 10+ years of relevant experience, particularly in managing the creation of regulated documents. Provide examples of your leadership in global project teams and your ability to produce high-quality documents.
Proofread and Edit: Before submitting your application, thoroughly proofread all documents for clarity, accuracy, and consistency. Ensure that your writing reflects the high standards expected in regulatory medical writing.
How to prepare for a job interview at Cpl Life Sciences
✨Showcase Your Expertise
As a Senior Manager in Regulatory Medical Writing, it's crucial to demonstrate your extensive knowledge in the field. Be prepared to discuss your experience with IND/IMPD and NDA/MAA components, as well as any specific projects you've led. Highlighting your technical expertise will set you apart.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and ability to lead teams. Think of examples from your past where you successfully navigated challenges in medical writing or regulatory submissions. This will showcase your strategic thinking and leadership capabilities.
✨Understand the Company’s Focus Areas
Research the company’s key areas such as immuno-oncology and gene therapy. Being knowledgeable about their focus will not only show your interest but also allow you to tailor your responses to align with their goals and values during the interview.
✨Demonstrate Strong Communication Skills
Given the importance of communication in this role, practice articulating your thoughts clearly and concisely. Be ready to explain complex regulatory concepts in simple terms, as this will reflect your ability to convey information effectively to diverse audiences.
