At a Glance
- Tasks: Lead the creation of high-quality regulatory documents for diverse clients in pharma.
- Company: Join Clinigen, a rapidly growing global specialty pharmaceutical services business.
- Benefits: Enjoy 27 days holiday, flexible benefits, and a discretionary bonus scheme.
- Other info: Collaborative environment with excellent career growth opportunities.
- Why this job: Make a real impact in drug development and support innovative medicines worldwide.
- Qualifications: Strong scientific background and medical writing experience required.
The predicted salary is between 36000 - 60000 € per year.
Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa. Clinigen is growing rapidly and is positioned well for an exciting future of continued expansion.
To support our continued growth, we are seeking a dynamic, detail-oriented and highly collaborative Strategic Regulatory Medical Writer to join our expanding team. This is a unique opportunity to work on diverse, project-based assignments with clients ranging from innovative biotech start-ups to global pharmaceutical organisations, supporting products across multiple therapeutic areas including oncology and orphan indications.
You will play a strategic role across the full drug development lifecycle, shaping high-quality regulatory documentation that directly supports agency interactions and marketing authorisation success. If you thrive in a fast-paced, intellectually stimulating environment and enjoy translating complex science into clear, compelling regulatory narratives, this role offers real impact and variety.
Key Responsibilities:- Lead the preparation and oversight of high-quality regulatory documents and slide decks, including briefing books, clinical trial documentation, and marketing authorisation submissions.
- Maintain Global Marketing Authorisations for allocated projects.
- Provide strategic regulatory writing support across the drug development lifecycle, from early clinical development to post-trial regulatory interactions.
- Work on project-based assignments with a diverse client base (small biotech to large pharma) across a range of therapeutic areas.
- Collaborate within small expert-led teams (Regulatory Project Manager & Writers), managing multiple projects with differing timelines.
- Own documents through all drafting stages, coordinating cross-functional input and SME review cycles, ensuring comments are effectively addressed.
- Interpret complex scientific and regulatory data to develop clear, strategically aligned regulatory narratives.
- Support clients in preparing for regulatory agency interactions, including scientific advice procedures.
- Contribute to regulatory intelligence activities and ensure documentation aligns with current EU regulatory frameworks (US knowledge advantageous).
- Strong scientific background with proven medical writing experience.
- Must be a strong RA professional who likes medical writing or a Medical Writer who likes regulatory strategy.
- Ideally 2-3 years pharma or consultancy experience.
- Strong scientific background, Lifesciences Degree.
- Solid understanding of EU regulatory frameworks (US knowledge desirable).
- Exceptional attention to detail and analytical mindset.
- Ability to manage multiple deadlines and complex review processes.
- Strong communication and collaboration skills.
- Understanding of regulatory framework and compliance.
- Understanding of the drug development and clinical research processes.
- Experience of authoring regulatory document for regulatory agencies.
- 27 days holiday plus bank holidays.
- Discretionary Bonus Scheme.
- Pension contributions 4.5% matched.
- Life assurance 4 x annual salary.
- Flexible Benefits Platform with £25/month Company contribution.
- Annual salary review.
- Independent financial advice service.
- Enhanced Employee Assistance Programme.
- Shopping discounts with retailers.
- Long service awards.
- Recognition scheme & employee of the year awards.
If you are a strategic thinker with a passion for regulatory excellence and want to make a tangible difference in bringing innovative medicines to patients worldwide, we would love to hear from you.
Strategic Regulatory Medical Writer in Bradford employer: Clinigen
Clinigen is an exceptional employer that fosters a dynamic and collaborative work culture, offering employees the chance to engage in meaningful projects across the pharmaceutical lifecycle. With a strong focus on employee growth, Clinigen provides extensive benefits including 27 days of holiday, a discretionary bonus scheme, and opportunities for professional development within a rapidly expanding global organisation. Located in the UK, this role as a Strategic Regulatory Medical Writer allows you to make a real impact while working alongside innovative biotech start-ups and leading pharmaceutical companies.
StudySmarter Expert Advice🤫
We think this is how you could land Strategic Regulatory Medical Writer in Bradford
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmaceutical and regulatory writing fields. Attend industry events or webinars, and don’t be shy about connecting on LinkedIn. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU regulatory frameworks and the drug development lifecycle. We recommend practising common interview questions and even role-playing with a friend. The more confident you are, the better you’ll shine!
✨Tip Number 3
Showcase your writing skills! Bring samples of your previous regulatory documents to interviews. This will not only demonstrate your expertise but also give you a chance to discuss your thought process and strategic approach. We love seeing how candidates think!
✨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, we’re always on the lookout for passionate individuals who want to make a difference in the pharmaceutical world.
We think you need these skills to ace Strategic Regulatory Medical Writer in Bradford
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the Strategic Regulatory Medical Writer role. Highlight your medical writing experience and any relevant regulatory knowledge to catch our eye!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory writing and how your background makes you a perfect fit for our team at Clinigen. Be genuine and let your personality come through.
Showcase Your Attention to Detail:As a detail-oriented role, we want to see that you can spot errors and ensure clarity in your writing. Make sure your application is free from typos and clearly structured to demonstrate your meticulous nature.
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 this exciting opportunity. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Clinigen
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of EU regulatory frameworks and the drug development lifecycle. Be ready to discuss how your experience aligns with the requirements of the role, especially in terms of preparing regulatory documents and interacting with agencies.
✨Showcase Your Writing Skills
Prepare samples of your previous regulatory writing work to demonstrate your ability to translate complex scientific data into clear narratives. This will not only highlight your writing skills but also your understanding of the strategic aspects of regulatory submissions.
✨Be Ready for Collaboration Questions
Since this role involves working within small expert-led teams, think of examples where you've successfully collaborated with others. Be prepared to discuss how you manage multiple projects and ensure effective communication across different stakeholders.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions about Clinigen’s approach to regulatory challenges or their future projects. This shows your genuine interest in the company and helps you gauge if it’s the right fit for you.
