Descripción de la oferta
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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