Job Title

Regulatory Writer - remotePRIMARY PURPOSE OF THE ROLETo provide high-quality, concise, and accurate regulatory documentation that meets the expectations of both clients and regulatory authorities.CORE RESPONSIBILITIESAuthor regulatory documents across various therapeutic areas, ensuring outputs are clear, factual, scientifically accurate, and free from over-interpretation.Adhere to established standard operating procedures and regulatory processes provided by clients.Demonstrate a foundational understanding of the expectations of regulatory authorities for submissions.Review client-supplied materials critically, including protocols, statistical analysis plans (SAPs), data listings, templates, and style guidelines.Assess documentation quality, data integrity, and project resource use—taking prompt action where issues are identified.Conduct accurate data checks of documents created by peers to ensure consistency and quality.Perform literature searches using publicly available or commercial databases to verify citations, locate references, and gather background context or regulatory precedent.Collaborate directly with clients to manage timelines and address emerging issues.Juggle multiple concurrent projects efficiently while meeting deadlines and maintaining quality standards.Proactively notify team members of risks or potential problems.Communicate clearly and professionally with internal team members and external contacts.Deliver work on time and within agreed-upon budgets.Follow internal and client-aligned procedures consistently.Contribute to additional duties as reasonably required to support project or business needs.CORE DELIVERABLES Produce a wide range of documents, which may include (but are not limited to):Clinical study protocolsClinical study reports (CSRs)Executive summariesCommon Technical Document (CTD) clinical summariesInvestigator brochures (IBs)Clinical trial authorisation (CTA) documentsPatient narrativesBENEFITSUnlimited Holiday Policy (including office closure between Christmas and New Years)Bonus schemeHealthcarePensionFlexible working hoursExtensive training development