Barrington James are exited to post a fantastic opportunity for one of our close clients. This company is a large pharmaceutical company in Europe that has exploded in size in recent years. They are backed by some serious investors the industry and are looking for future support within their Medical Writing team. This opportunity is prefect for someone who is ambitious, independent and wants to play a key role in working on the most innovative projects.
Key Responsibilities
* Author and lead development of clinical and regulatory documents, including:
* Clinical Study Protocols (CSPs)
* Clinical Study Reports (CSRs)
* Module 2 summaries (CTD)
* Regulatory briefing documents
* Support global submissions (e.g. IND, CTA, NDA, MAA)
* Interpret and present complex clinical and scientific data clearly and accurately
* Collaborate with:
* Clinical Development
* Regulatory Affairs
* Ensure compliance with:
* ICH guidelines
* Regulatory authority requirements (FDA, EMA)
* Internal SOPs and style guides
* Contribute to document strategy, planning, and timelines
* Participate in review cycles, incorporating cross-functional feedback
Requirements
* 5–10 years medical writing experience within pharma / biotech
* Strong background in regulatory and clinical writing
* Demonstrated experience in oncology (essential)
* Proven experience supporting global submissions
* In-depth knowledge of:
* CTD structure
* Ability to work independently in a fast-paced, matrixed environment
* Excellent written communication and stakeholder management skills
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