Labcorp job opening for Medical Writer Asst
- Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating
procedures, and assume accountability for the deliverables
- Ensure compliance of operations with governing regulatory requirements
- Create, maintain and assume accountability for a culture of high customer service
- Perform literature searches (clinical and non-clinical) and write non-clinical and clinical submission documents
- Write parts of various safety reports for global regulatory submissions for Labcorp’s clients, including Annual Reports (IND and other), Periodic Safety
Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports
- Assist in writing Investigator brochures and sections of protocols
- Assist in writing Clinical Study Reports for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses
- Assist pharmacovigilance teams in writing narratives for the adverse drug reactions and adverse events they process
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