Mr.Fox! schreef op 26 februari 2021 14:32:
Nieuwe vacature! En wat voor één:
The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Medical Writer for our HQ in Leiden.
About the role:
In collaboration with colleagues of the Regulatory Affairs, Medical Affairs, Clinical, non-Clinical, and Pharmacovigilance departments, the Medical Writer creates/compiles documents that are required for regulatory submissions to Competent Authorities, based on scientific knowledge and applicable ICH, clinical, and (local) regulatory guidance and legislation.
Compile, write, and edit medical writing deliverables for submission to regulatory agencies such as FDA and EMA, covering all phases of clinical research and post-approval medical activities.
Experience in writing/compiling medical documents for regulatory submissions such as clinical study protocols and clinical study reports, Investigator’s Brochures, Clinical Overviews (M 2.5) and Clinical Summaries (M 2.7)