Snr Medical Writer- Medical Affairs
- Experience Level
- Experienced (non-manager)
Role – Senior Medical Writer
Location – UK, Belgium, France, Sweden, Poland or Spain
Salary – Competitive based on experience
Due to company growth our client, a European CRO, is looking to recruit medical writers to support their Medical Affairs unit as soon as possible.
Who are you?
You will be an experienced medical writer, ideally with a master’s degree in a scientific discipline with good knowledge of the drug development process, ICH-GCP guidelines and the methodology of clinical research. You will be fluent in English with excellent planning and organisational skills and love to work within an international team.
Typical responsibilities will include
-Draw up, edit, and review preclinical/clinical documents such as clinical study reports, study protocols, patient information and informed consent forms and other medical and regulatory documents.
- Develop scientific manuscripts and abstracts reporting clinical study results, as well as slide and poster presentations.
- Prepare regulatory and preclinical/clinical documents for drug development and registration activities
- Take ownership of a given assignment, proactively collaborating with Biometrics staff, Pharmacovigilance and Clinical Operations Units for information or guidance, as necessary.
- Coordinate and manage documents to be sent to customers.
- Perform literature searches and reviews necessary to obtain information for the development of documents
- Be familiar with, and work in accordance with Regulations, Good Clinical Practices and ICH guidelines and Company Standard Operating Procedures
- Create and maintain audit trail of all the document changes
- Review the quality and accuracy of the documents in English.
This is a great opportunity to join an established company with exciting growth plans .For further information please contact Louise Clark on +44 (0)1293 584300