Senior Manager, Regulatory Medical Writing

Senior Manager, Regulatory Medical Writing

Senior Manager, Regulatory Medical Writing

Get AI-powered advice on this job and more exclusive features.

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

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

Referrals increase your chances of interviewing at Cpl Life Sciences by 2x

Sign in to set job alerts for “Manager Medical Writing” roles.

Business Development Director, Clinical Pharmacology - Pharma Sales

Senior/Account Director, Business Development (Early Phase Clinical Development)

Senior Medical Writer - Medical Communications

London, England, United Kingdom 1 week ago

London, England, United Kingdom 2 months ago

Senior Medical Writer - Specialist HEOR & Access Consulting firm

Senior Medical Writer - Medical Affairs/Publications

London, England, United Kingdom 2 weeks ago

London, England, United Kingdom 2 months ago

Single Sponsor Principal/Senior Clinical Medical Writer - (fully home based)

Harrow, England, United Kingdom 3 weeks ago

Senior/Principal Regulatory Medical Writer (client-embedded) EMEA

Technical Reviewer - Active Medical Devices

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr

Full job description from WhatJobs. Apply for this role →