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.
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.
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53857 in all correspondence.
You must have the right to work in the UK. Learn more
- Agency: CK Group
- Reference: 53857
Website: CK Group
- Posted: 13th June 2022
- Expires: 11th July 2022