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For Companies At a Glance
- Tasks: Write and review high-quality regulatory documents for global health authorities.
- Company: Join Omnicom Health Regulatory, a leader in regulatory writing and scientific services.
- Benefits: Hybrid work model, career growth, and access to a global network of expertise.
- Why this job: Make a real impact in the pharmaceutical industry while developing your regulatory writing skills.
- Qualifications: Experience in regulatory writing and strong understanding of client guidelines.
- Other info: Collaborative team environment with opportunities for mentorship and professional development.
The predicted salary is between 36000 - 60000 £ per year.
United Kingdom - London, England, United Kingdom - Macclesfield, England
Work Arrangement: Regular - Hybrid, Regular - In-Office
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.
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 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.
Part of the IPG Health network, at Complete Regulatory we are a specialized group of experienced regulatory writers proficient in providing high-quality regulatory writing and project management services. Our expertise covers a wide range of therapy areas across the full spectrum of clinical regulatory writing. The way we work is the difference that we bring: Complete Regulatory writers work together as an agile and responsive extension of your team, bringing flexibility and value when you need it most. We bring genuine passion and a personalized approach to the distinct needs of every client company.
Senior Regulatory Writer employer: Neon Nyc
Contact Detail:
Neon Nyc Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Writer
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory writing field and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a job opening or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory guidelines and recent industry trends. Show that you’re not just a writer, but someone who understands the bigger picture and can contribute to strategic discussions.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the needs of the role. Highlight your ability to manage timelines and produce high-quality documents under pressure—this is key for a Senior Regulatory Writer.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at Omnicom Health Regulatory.
We think you need these skills to ace Senior Regulatory Writer
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Senior Regulatory Writer role. Highlight your experience in writing regulatory documents and your understanding of client guidelines. We want to see how you can bring your unique skills to our team!
Showcase Your Expertise: Don’t hold back on showcasing your technical writing expertise! Include specific examples of documents you've worked on, especially those related to high-level submissions. This will help us see your depth of knowledge and how you can contribute to our projects.
Be Clear and Concise: When writing your application, clarity is key. Use straightforward language and avoid jargon unless necessary. We appreciate well-structured applications that are easy to read, just like the documents we produce!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen to join our team at Omnicom Health Regulatory!
How to prepare for a job interview at Neon Nyc
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines relevant to the role. Familiarise yourself with the types of documents you'll be working on, like clinical study protocols and regulatory submissions. This will show that you're not just a writer, but someone who understands the regulatory landscape.
✨Showcase Your Writing Skills
Prepare samples of your previous work that highlight your ability to produce high-quality, accurate regulatory documents. Be ready to discuss your writing process and how you ensure clarity and compliance in your work. This is your chance to demonstrate your expertise!
✨Be a Team Player
Since collaboration is key in this role, think of examples where you've successfully worked with others. Whether it’s mentoring junior writers or leading client meetings, be prepared to share how you foster teamwork and build positive relationships. This will resonate well with the interviewers.
✨Manage Your Time Like a Pro
Given the fast-paced nature of regulatory writing, be ready to discuss how you handle conflicting timelines and manage your workload. Share specific strategies you use to stay organised and proactive in addressing challenges. This will highlight your ability to thrive under pressure.