Regulatory Medical Writer
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 andregulatory 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: For more information or to apply for this Regulatory Medical Writer position, please contact Hendre Moolman on 01438 842970 or email firstname.lastname@example.org quoting job ref 53857.
It is essential that applicants hold entitlement to work in the UK.