You’ll work closely with internal stakeholders and report to the Associate Director – Regulatory and Medical Writing.
Ideal for someone who can work independently, think laterally, and pitch in wherever needed to keep programs moving.
About the Role
In this dynamic role, you will contribute to all aspects of medical and regulatory writing with a focus on oversight, independent QC, and hands-on development of key documents, particularly those that are time-sensitive or require internal ownership.
Key responsibilities include:
- Preparation of high-quality clinical and regulatory documents.
- Managing the full document lifecycle from drafting through review, amendment, and finalisation.
- Acting as an independent QC layer, ensuring documents comply with GCP, internal processes, and applicable local and international regulations
- Supporting low-level regulatory affairs activities, including administrative back-and-forth associated with IND submissions
- Final PDF publishing and preparation of documents for regulatory submissions
- Collaborating with cross-functional internal teams and external partners to deliver high-quality documents aligned to project timelines
- Maintaining accurate and up-to-date information in project trackers, regulatory databases, and document management systems
- Providing operational and administrative support across medical and regulatory activities where required
- Supporting programs across US and EMEA regulatory landscapes
- Developing and maintaining scientific, medical, and technical knowledge relevant to the company’s clinical studies and pipeline
You’re a clear, meticulous writer with strong attention to detail who thrives under pressure and adapts quickly to evolving priorities. You’re comfortable managing multiple workstreams, negotiating timelines, and incorporating feedback — without needing close supervision.
You will bring:
- A minimum of 3+ years’ experience in medical/scientific writing within pharma, biotech, CRO, medical communications, or related industries
- A solid understanding of the clinical trial environment (GxP) and applicable regulatory guidelines
- Experience translating complex scientific concepts into clear, plain-language documents
- Exposure to regulatory writing and low-level RA activities
- Exceptional written and verbal communication skills and strong grammar
- A collaborative, pragmatic mindset — not overly aggressive or political
- Flexibility, agility, and a willingness to pitch in as the company grows
- Hands-off management style with strong support when needed
- Open, collaborative culture
- Fast-paced work with demanding deadlines — efficiency and accuracy are critical
- Opportunity for growth and progression as the organisation scales
- Flexible locations and hybrid working arrangements.
If you’re an adaptable medical writer who enjoys variety, autonomy, and making things happen in a growing biotech, we’d love to hear from you.
