We’re currently collaborating with a global, award-winning medical communications agency to support their search for an experienced Senior Regulatory Medical Writer. This is a unique opportunity to join a high-performing regulatory writing team, with exposure to international projects, complex document types, and strategic input in client programs.
About the Role:
As a Senior Regulatory Medical Writer, you will independently lead the development of a wide range of core regulatory documents across various therapeutic areas. You’ll act as a primary point of contact for clients, support junior writers, and provide critical input on project strategy and delivery — all while working in a collaborative and supportive environment.
This role is ideal for a confident communicator and experienced writer who thrives on ownership, autonomy, and the opportunity to mentor others.
Key Responsibilities:
* Independently produce a range of high-quality regulatory documents (e.g., CSRs, protocols, IBs, CTD summaries, narratives)
* Critically review and provide strategic input into client documentation
* Act as a lead writer across multiple projects, overseeing timelines, quality, and team resourcing
* Coach and mentor junior writers, contributing to team knowledge sharing and best practice
* Serve as the expert point of contact for both internal stakeholders and external clients
* Participate in client meetings and proactively address issues and risks
* Ensure compliance with SOPs, industry regulations, and document standards
Ideal Candidate Profile:
* Minimum of 5 years' regulatory writing experience in a medical communications agency or pharma/biotech setting
* Proven experience as lead writer across at least 3 document types (e.g., protocols, CSRs, IBs, Module 2.7 documents)
* BSc or PhD in life sciences (PhD preferred)
* Strong understanding of ICH and regulatory authority requirements
* Experience managing client relationships and project timelines
* Comfortable mentoring junior writers and delegating tasks effectively
* Ability to work independently and lead document strategy discussions
* Exceptional written and verbal communication skills
What’s on Offer:
* Work with a global client base across therapeutic areas
* Highly supportive team culture and leadership
* Flexible/hybrid working options
* Strong focus on professional development and mentoring
* Opportunities for strategic project involvement and business development exposure
* Career progression pathways within a growing team