Senior Regulatory Writer REMOTE

Job DescriptionWere 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. Youll 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 documentationAct as a lead writer across multiple projects, overseeing timelines, quality, and team resourcingCoach and mentor junior writers, contributing to team knowledge sharing and best practiceServe as the expert point of contact for both internal stakeholders and external clientsParticipate in client meetings and proactively address issues and risksEnsure compliance with SOPs, industry regulations, and document standardsIdeal Candidate Profile:Minimum of 5 years' regulatory writing experience in a medical communications agency or pharma/biotech settingProven 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 requirementsExperience managing client relationships and project timelinesComfortable mentoring junior writers and delegating tasks effectivelyAbility to work independently and lead document strategy discussionsExceptional written and verbal communication skillsWhats on Offer:Work with a global client base across therapeutic areasHighly supportive team culture and leadershipFlexible/hybrid working optionsStrong focus on professional development and mentoringOpportunities for strategic project involvement and business development exposureCareer progression pathways within a growing team

Created: 2025-06-27