Senior Regulatory Writer

Omnicom Health Medical Communications; Macclesfield; On-site; GBP 60,000 - 90,000; Full time

Job summary

Omnicom Health Regulatory seeks a Senior Regulatory Writer to join a growing team, focusing on strategic, high‑level submissions and materials for global health authorities. You will write and review a broad range of regulatory documents and mentor junior writers, while collaborating with clients and internal teams to ensure regulatory compliance and timely delivery.

The role requires strong scientific accuracy, regulatory insight, and the ability to manage multiple projects and client

Qualifications

• Experience writing and reviewing regulatory documents for global health authorities.
• Ability to mentor junior writers and share expertise.
• Strong client-facing skills and ability to manage expectations and timelines.
• Understanding of regulatory guidelines and project budgets.

Responsibilities

• Review and critically evaluate source information.
• Write high‑quality, accurate regulatory text for diverse documents.
• Advise internally and to clients on regulatory needs and guidelines.
• Brief teammates on document requirements and schedules.
• Review work for readability, accuracy and fit for purpose.
• Manage workload and timelines; address challenges proactively.

Skills

Mentor and coach

Team coaching

Client relationship building

Lead client meetings

Commercial/financial awareness

Business development

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.

What you’ll bring

• 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 the relevant line manager to understand the capabilities and training plans for writers when coaching.
• Work with and support other team members to ensure strong teamwork and consistency/best practice.
• Build positive relationships with clients by providing a knowledgeable point of contact; contribute to discussions to identify issues and recommend solutions, effectively agreeing schedules and resolution of issues.
• Confidently lead and facilitate client meetings.
• Demonstrate robust commercial/financial awareness of project budgets and scopes of work; work with senior team members to identify issues and support good recoverability.
• Participate in business development by assisting in developing relationships with new clients.

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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