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)
Key Requirements:
* 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
Benefits:
* 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.