Regulatory Medical Writer

1 week ago


New Works, United Kingdom CK GROUP Full time

CK Group are recruiting for Regulatory Medical Writer to join a medical writing company in the pharmaceutical industry working remotely on an initial 6-12 month contract basis (outside IR35).
**Regulatory Medical Writer Role**:
The main purpose of the role will be to:

- Write clear, concise regulatory documentation.
- As a specialist writer, ensure smooth progress from submission to approval as you are involved in authoring various regulatory documents.
- Work on core dossier preparation and regulatory responses.

**Further responsibilities will include**:

- Writing integrated safety and efficacy summaries.
- Authoring clinical study reports (Phase I - IV) and Clinical Evaluation Reports (CERs).
- Composing non-clinical reports and briefing documents.

**Your Background**:
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

- Life Science degree or higher qualification (MSc, or PhD).
- Proven experience authoring the majority of Regulatory documents (CTDs, NDAs, MAAs, CERs, CSRs).
- Experience in quality checking material.
- Therapy experience in Oncology would be advantageous.

**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53857 in all correspondence.



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