Thor Companies
Our client is a leading and award winning CRO, specialised in conducting oncology trials across the world. They continue to lead the way in support of science and innovative therapies for the development of cancer related drugs.
We are asked to help them identify a highly collaborative Senior Medical Writer to join their team, reporting directly to executive level.
Responsibilities
Clinical study protocols and protocol amendments
Investigator’s brochures and updates
Interim and final clinical study reports
IND annual reports
Development safety update reports
Patient informed consent forms
Provide guidance and support to other in-house units in preparation or review of manuals, training guidelines and similar documents
Serve as a resource for new medical writers
Experiences;
5+ years prior experience in a CRO/pharmaceutical environment
3+ years prior relevant experience in regulatory Medical Writing (oncology experience preferred)
Lead writer experience with at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures, Development Safety Update Reports, IND applications
Experience working directly with clients/Sponsors, preparing document timelines, organizing review cycles, and coordinating review meetings
Contact : +46 73 525 10 59