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Medical Writer

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Medical Writer in remote new

  • GlaxoSmithkline
  • Part time
  • Email

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 Labcorp is proud to be an Equal Opportunity Employer: As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status. For more information about how we collect and store your personal data, please see our Privacy Statement.



GlaxoSmithkline

Our?Pharmaceuticals business?has a broad portfolio of innovative and established medicines in respiratory, HIV, immuno-inflammation and oncology. We are strengthening our R&D pipeline through a focus on immunology, human genetics and advanced technologies to help us deliver transformational new medi...

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