CMC Writer
- Wavre
For one of our clients, located in Wavre, we our currently looking for 2 "CMC Writers". The Technical RA manager is responsible for the preparation, authoring and coordination of CMC submissions related to China Compliance remediations program. * Ensure coordination of activities related to CMC submission file preparation, including change control assessment, source documents collection from key contributing discipline (eg GIO,QC, Site Conformance, etc), initiation and management of CMC submission kick-off meeting,file authoring, review and approval. * Experience in CMC authoring of technical file - Oxford Global Resources * Wavre * Contract duration specified * Full Time - Your responsibilities - Job Description - The person will also be required to interact with regulatory and technical contributing disciplines Teams to ensure File content - definition, submission strategy and preparation coordination.
For one of our clients, located in Wavre, we our currently looking for 2 "CMC Writers". The Technical RA manager is responsible for the preparation, authoring and coordination of CMC submissions related to China Compliance remediations program. * Ensure coordination of activities related to CMC submission file preparation, including change control assessment, source documents collection from key contributing discipline (eg GIO,QC, Site Conformance, etc), initiation and management of CMC submission kick-off meeting,file authoring, review and approval. * Experience in CMC authoring of technical file - Oxford Global Resources * Wavre * Contract duration specified * Full Time - Your responsibilities - Job Description - The person will also be required to interact with regulatory and technical contributing disciplines Teams to ensure File content - definition, submission strategy and preparation coordination.
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