Clinical & Regulatory Lead Author

5 days ago


New Works, United Kingdom CK GROUP Full time

CK Group are recruiting for a Clinical & Regulatory Lead Author to join a company in the Pharmaceutical industry working remotely, initially on a contract basis for 12 months.
**Daily Rate**:
£500 per day LTD - this role is outside IR35
**Essential Requirements**:

- It is essential that applicants hold entitlement to work in the UK
- Bachelor Degree in Life Sciences or MSc or PhD in Life Sciences (preferred)
- More than 3 years’ relevant writing experience of study-related and submission-related clinical and regulatory documents
- Experience of writing protocols, CSRs, IBs, Briefing Documents
- Experience of wiring relevant documents for more than 3 drug products in Oncology and Immuno-oncology

**Clinical & Regulatory Lead Author Role**:

- Leading the delivery for individual documents, setting clear expectations for completion of assignments to expected timelines and quality.
- Leading scientific discussions within assigned documents, driving the clinical interpretation of data and information and condensing it into clear, concise and accurate messages.
- Engaging proactively and effectively with documents stakeholders, navigating their different viewpoints and objectives.
- Anticipating issues and proposing effective solutions for individual documents, escalating as needed.
- Serve as a knowledgeable resource on regulatory requirements (eg. GCP, ICH, CTD) and relevant internal/ external guidelines.

**Company**:
Our client is a global research-based bio pharmaceutical company with a major UK presence who are committed to making a meaningful impact on people’s lives with life-changing medicines. This is a worldwide brand name which will not only look fantastic on yourCV for years to come but also offer inspiring and rewarding work.
**Location**:
Remote.
**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54567 in all correspondence.
**Please note**:



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