At a Glance
- Tasks: Lead the creation of high-quality regulatory documents for diverse clients in the pharmaceutical industry.
- 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: Dynamic environment with opportunities for career growth and recognition.
- Why this job: Make a real impact in drug development while collaborating with innovative biotech and pharma companies.
- Qualifications: Strong scientific background and medical writing experience required; 2-3 years in pharma preferred.
The predicted salary is between 28800 - 48000 £ 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 Cambridge 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, employees enjoy a stimulating environment where their contributions directly impact the success of innovative medicines reaching patients worldwide.
StudySmarter Expert Advice🤫
We think this is how you could land Strategic Regulatory Medical Writer in Cambridge
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Clinigen. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Clinigen.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Clinigen. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Clinigen is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Strategic Regulatory Medical Writer in Cambridge
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Clinigen!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Clinigen that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Clinigen!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Clinigen, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Clinigen
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Clinigen that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Clinigen’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
