Regulatory Documentation Scientist
Mary Tilston at CK Clinical is recruiting for a Medical Writer (Regulatory Documentation Scientist) to join a company in the Pharmaceutical industry at their site based in Hertfordshire on a permanent basis.
The main purpose of the role will be to:
- Prepare documents to meet the evolving needs of health authorities, using expertise in writing, science and regulatory requirements.
- Manage the preparation of safety and clinical documents, ensuring that they are of the highest quality and in line with internal/ external guidelines and requirements.
- Work with global drug development teams to bring the product to patient through planning and preparing a broad range of clinical and safety regulatory documents.
Further responsibilities will include:
- Liaising and working closely with colleagues in safety science, biostatistics, clinical science and regulatory affairs, working on projects across a range of therapeutic areas.
- Working on periodic safety reports, risk management plans, clinical safety reports and clinical summaries amongst many others.
- The opportunity to contribute to best practices and continuous improvement.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Knowledge of guidelines relating to safety and or clinical reports is crucial.
- PhD, MSc or equivalent in a biomedical discipline or qualification in pharmacy, nursing or another healthcare discipline.
- Previous medical writing experience.
- Working within the pharmaceutical industry, either directly, through a contract research organisation or on a freelance basis.
This is an excellent opportunity to combine your scientific knowledge and writing skills in an important role with one of the worlds leading healthcare companies.
For more information or to apply for this position, please contact Mary Tilston on 01438 768717 or email MTilston@ckclinical.co.uk. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL33040 in all correspondence.