At a Glance
- Tasks: Write and review regulatory documents for global health authorities, ensuring accuracy and compliance.
- Company: Join Omnicom Health, a leader in regulatory writing and scientific services.
- Benefits: Career growth, supportive team, and the chance to specialise in regulatory writing.
- Other info: Flexible remote work with a focus on collaboration and mentorship.
- Why this job: Make a real impact in healthcare by supporting the development of new medicines.
- Qualifications: Experience in regulatory writing and strong understanding of client guidelines.
The predicted salary is between 45000 - 55000 £ per year.
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. 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.
- 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.
- Work with relevant line manager to understand the capabilities and training plans for writers when coaching.
- Demonstrate robust commercial/financial awareness of project budgets and scopes of work.
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 will process your personal data in accordance with our Recruitment Privacy Notice.
Location: Macclesfield, Cheshire, United Kingdom
Type: Full time
Locations
Regulatory Writer Remote in Cheshire, Macclesfield employer: Momentum Worldwide
Hearts & Science is an exceptional employer that fosters a dynamic and inclusive work culture in the heart of London. With a strong commitment to employee development, we offer numerous growth opportunities and encourage innovative thinking, ensuring that our team members are equipped to turn challenges into competitive advantages for our clients. Join us to be part of a collaborative environment where your contributions are valued, and you can make a meaningful impact on global brands.