Senior Regulatory Writer

Agency: Omnicom Health Medical Communications Job Function: Medical Scientific Services Job Subfunction: Medical Writing Job Description: Company Overview Omnicom Health Regulatory is a global, market-leading regulatory writing and scientific services group within the Omnicom Health network. By combining the established legacies of Complete Regulatory, HCG, and ProEd, we have created a new powerhouse in the regulatory field - bringing together deep technical writing expertise with high-level scientific and regulatory consultancy. Our teams support pharmaceutical and biotech clients across the full clinical development lifecycle, delivering technically rigorous, high-quality regulatory documentation to support the development, submission, and approval of medicines worldwide. We produce a wide range of regulatory documents, including clinical study protocols and reports, investigator’s brochures, regulatory submission documents, response documents, patient narratives, and strategic briefing materials for global health authorities. As a global offering, Omnicom Health Regulatory works closely with clients, internal partners, and regulators across regions and therapeutic areas. We are known for our scientific accuracy, attention to detail, regulatory insight, and collaborative approach. Our structure allows individuals to develop deep specialism within regulatory writing while also broadening their experience across document types, development phases, and strategic regulatory engagements. Senior Regulatory Writer We are seeking experienced Senior Regulatory Writers to join our growing team. You will play a key role in writing and reviewing a broad range of regulatory documents, with a particular focus on strategic, high-level submissions and materials for global health authorities. Key Responsibilities

• Review and critically evaluate source information.
• Work at pace and write high-quality, accurate text for a wide range of documents.
• Demonstrate a good understanding of the needs of regulatory authorities and client guidelines and use this to provide advice internally and to clients for all types of regulatory documents.
• Brief other team members to support all types of documents, including time allocations, and document requirements.
• Review project work by assessing how well the documentation meets client and regulatory requirements and the appropriateness of material, in terms of readability, accuracy and ‘fit for purpose’.
• Manage workload and conflicting timelines effectively and proactively address any potential challenges with new or existing projects.

• Mentor and coach less experienced Regulatory Writers and contribute to the training of new Regulatory Writers.
• Contribute to sharing existing expertise and acting as a role model; work with relevant line manager to understand the capabilities and training plans for writers when coaching.
• Works with and supports other team members to ensure strong te