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 Pro.

Ed, 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.

Job Summary

• Bring excellence in regulatory writing to complex and multi-document projects, demonstrating expert skill, knowledge, and leadership across the full range of regulatory writing projects, delighting clients and supporting colleagues along the way.
• Autonomy in leading the development of a broad range of projects, including complex and non-standard projects, and new types of projects for the agency.
• Expertise in coaching and mentoring and confidently briefs and reviews for writers of all levels.
• Promotes best practice and excellence in medical writing across the business.
• Work closely with other senior colleagues to develop products/services and refine internal processes to help ensure that the agency is operating efficiently and appropriately. A trusted advisor and partner to the client.

Job Responsibilities

Regulatory Writing Excellence

• Produce, and co-ordinate production of, a wide range of regulatory documentation in accordance with the needs of the client and of regulatory authorities.
• Manage multiple projects, taking overall responsibility for successful delivery and instilling accountability in others.
• Rapidly assimilate clinical development data and objectively evaluate source information; grasp key issues for regulatory documents and understand their context.
• Demonstrate an excellent understanding of the needs of regulatory authorities and use this to provide advice internally and to clients. Keep abreast of developments and requirements of regulatory authorities for relevant documentation.
• Pick up and assess complex, non-standard, or new project types and progress these efficiently and appropriately; quickly get up to speed with new therapy areas and processes.
• Act as a key source of expertise for projects, including advising internally on client’s standard operating procedures and processes and liaise with client to provide feedback and suggested improvements.
• Enable team to produce documentation that meets client and regulatory requirements and is appropriate, in terms of readability, accuracy and ‘fit for purpose’.
• Manage workload effectively, and prioritize/reprioritize effectively, to meet deadlines for fast-paced and multiple parallel projects. Support less experienced team members in task prioritization.
• Participate in formal and on-the-job training, complete assigned training to the required standard and within the given timeframes. Provide feedback on training to support program development. Internal Leadership / Development of Others
• Liaise with resourcing lead to manage assignment of resource and to contribute to resource forecasting, as required. Identify elements of projects that can be supported by other writers and freelancers, including opportunities for training.
• Lead, coach and motivate project teams, providing support and guidance to team members on client and project issues, leading troubleshooting discussions regarding project delivery and establishing clear guidelines and ways of working for more complex projects to ensure consistency and efficiency.
• Use proven track record to coach, mentor, brief, and review work for writers of all levels.
• Enable team to produce documentation that meets client and regulatory requirements and is appropriate, in terms of readability, accuracy and ‘fit for purpose’.
• Provide strategic leadership in leading multi-document projects and co-ordinating the work of other team members.
• Develop close working relationships with team members thereby enabling provision of regular feedback on performance, both directly and to line managers.
• Actively participate in the effective and efficient implementation of Complete Regulatory training and development, coaching individual team members and leading workshops, where required.
• Proactively share extensive knowledge and experience with team members, working collaboratively to help meet team objectives.
• Work closely with senior colleagues to ensure that a client-focused and high-performance culture is maintained within Complete Regulatory.
• Use experience and knowledge to contribute to Complete Regulatory Process improvement. Client Service
• Liaise effectively with the client, acting as the primary point of contact overseeing a group of projects or submission; effectively anticipating or troubleshooting any objections from clients to ensure continuing good relationships.
• Build positive relationships with clients by being a knowledgeable point of contact and providing strategic advice; contribute to discussions to identify issues and recommend solutions.
• Confidently lead any type of meeting and offer strategic advice to clients; contribute to complex or sensitive client meetings. Commercial / Financial
• Demonstrate robust commercial/financial awareness and awareness of budget and scope for each project and communicate this with team members; work with senior team members to identify issues and support good recoverability.
• Meet individual chargeability levels and support other team members to meet chargeability levels. Business Development
• Maintain and secure profitable ongoing business and expand opportunities on projects.
• Participate in business development by assisting in developing relationships with new clients.
• Contribute to, and participate in, new proposal development and pitches where appropriate.
• Collaborate with other agencies where appropriate. What You’ll Get in Return This role offers the opportunity to build your career within a highly specialised, supportive, and talented regulatory team, while benefiting from the scale, global reach, and multidisciplinary expertise of the wider Omnicom Health network. You’ll have the opportunity to specialise within regulatory writing while also expanding your knowledge across strategic submissions, global regulatory pathways, and therapeutic areas—within a truly one-of-a-kind regulatory offering.

Omnicom’s policy requires employees to work in the office for a minimum of three days a week, unless additional in-office days are directed by their agency or manager. Our objective is to increase this requirement over time, and many of our agencies as well as Omnicom’s corporate group already require five days of in-office attendance.

Omnicom is committed to hiring and developing exceptional talent. We agree that talent is uniquely distributed, and we’re focused on developing inclusive teams that can bring the best solutions to everything we do. We strongly believe that celebrating what makes us different makes us better together. Join us—we look forward to getting to know you.

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