Job Overview
- Drafts protocols and reports for clinical studies on cosmetics or other claims.
- Uses internal or client template, study outline, clinical data, International Council on Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines, and other relevant information.
- Coordinates internal and external protocol reviews and obtains client agreement
- Writes and reviews ICH/GCP-adherent clinical study protocols, coordinates internal and external reviews, and obtains client agreement by project deadline
- Drafts clinical study reports based on internal or client template according to clinical data, protocol and amendments and deviations; revises reports based on reviews by quality assurance, statistics department, investigators, client, and others
- Assists in maintaining internal databases of protocol and report templates, bioinstrumentation specifications, clinical grading parameters, and client preferences
- Assists in drafting and editing Standard Operating Procedures (SOPs) and Work Instructions (WI) for department as assigned
- Completes training within required deadline
- Adheres to internal standards, policies, and procedures
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