About the role:
ARTO Recruitment are partnering with a top Pharmaceutical company that has a need for two Pharmacovigilance Medical Writers to join their team on a permanent basis.
This role is home based with a monthly trips to their offices in their office in the UK.
Within this role the PV Medical Writer applies intermediate to advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalisation of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
• Drafts and edits documents used for submissions including CTDs and RtQs
• Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms
• Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PSURs, DSURs, etc.)
• Manages study team participation in the preparation of such documents including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
• Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
• Works effectively with cross-functional groups
• Other tasks as assigned.
In order to be considered for this role, you will possess a Life Science Degree. You will have experience within Medical writing within the Pharmaceutical Industry with experience of writing, reviewing, or editing protocols, clinical study reports, INDs and BLA/NDAs