Sector: Life Sciences
Consultant: Chris Hutchinson
Salary: £20000 - £40000
Job Status: Permanent / Full Time
Regulatory Affairs Writing Associate
My client is seeking a motivated individual with a science, research and / or writing background who would like the opportunity to join our Regulatory Affairs/Medical Writing team and be involved in the development of new products being evaluated for the treatment of cancer.
As well as a strong interest in Medical Writing, the ideal applicant will also have the ambition to develop their Regulatory Affairs capabilities.
The primary responsibilities of this position include, but are not limited to, the following:
Country specific patient informed consent forms and other documentation given to patients related submissions and approvals.
Initial clinical trial applications, amendments and other authority and/or ethics committee
Annual Reports required by regulatory agencies and ethics committees.
Other clinical trial related documentation, as required.
Acts as a peer reviewer for the above submissions and documents.
Maintains logs and tracking of IND/CTAA and amendment submissions.
Serves as a key liaison for multi-continental projects on behalf of Theradex Oncology (Europe). Liaison with other departments within Theradex, including Data Management, Regulatory, Medical Writing, Pharmacovigilance, Quality Assurance and Drug Distribution.
Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by regulatory agencies.
Any candidate for this position need to have pre-existing experience in writing ICFs (Informed consent forms)
We are looking for a science graduate with at least 6 months of experience in a regulatory environment and previous writing experience, for example scientific and/or clinical documents. Some familiarity with industry principles of drug safety, US and international regulatory guidelines (e.g. ICH-GCP), drug development, pharmacology, clinical trial methodology, and oncology would be advantageous although not mandatory.