Medical Writer Asst Full-time Job

1) 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

2) Ensure compliance of operations with governing regulatory requirements

3) Create, maintain and assume accountability for a culture of high customer service

4) Perform literature searches (clinical and non-clinical) and write non-clinical and clinical submission documents

5) Write parts of various safety reports for global regulatory submissions for Labcorps clients, including Annual Reports (IND and other), Periodic Safety

Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports

6) Assist in writing Investigator brochures and sections of protocols

7) Assist in writing Clinical Study Reports for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses

8) Assist pharmacovigilance teams in writing narratives for the adverse drug reactions and adverse events they process

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