Sr. Medical Writer 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/review non-clinical and clinical submission documents

5 Write/Review 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 6 Write Investigator brochures and sections of protocols 7 Write Clinical Study Reports in whole or in part for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses 8 Act as a writing coach 9 Coordinate activities related to various types of report writing across a team of writers if applicable 10 Liaise with client and act as a primary point of contact for all report writing activities 11 Perform various support activities such as tracking, maintenance of metrics, quality checks and training

11 Assist in estimation of resource requirement and responding to RFPs as needed

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