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  • Medical writer consultant needs 5 years medical writing experience in clinical development function at a pharmaceutical company or cro remote srmedical writer consultant requires: • strong written and verbal communication skills, including fluency in oral and written english, with the ability to clearly present clinical data• bachelor’s degree in a relevant scientific field is required; advanced degree preferredmedical writer consultant duties: • draft, edit, format, and finalize clinical regulatory documents including, but not limited to: clinical protocols and amendments, investigator’s brochures (ibs), and clinical study reports (csrs)• ensure a consistent style of presentation of clinical documents to maintain quality and ease of review, and adherence to company standardscom/jobopenings   remote srglobalchannelmanagement• assist in the development of templates and standard operating procedures (sops)• produce high quality and on-time writing deliverables to support the activities and goals of the clinical study team(s), clinical program, and the medical writing function• regulatory submissions and knowledge of ectd formatting preferred• facilitate efficient review and finalization process of documents produced internally and externally by contractors and vendors• provide quality control (qc) review of clinical regulatory documents, as appropriate• represent medical writing on one or more program teams • participate in medical writing initiatives, and process improvement, as appropriate • collaborate cross-functionally and ensure key messages are consistently aligned in the preparation of clinical regulatory documents

  • Medical writer consultant needs 5 years medical writing experience in clinical development function at a pharmaceutical company or cro remote srmedical writer consultant requires: • strong written and verbal communication skills, including fluency in oral and written english, with the ability to clearly present clinical data• bachelor’s degree in a relevant scientific field is required; advanced degree preferredmedical writer consultant duties: • draft, edit, format, and finalize clinical regulatory documents including, but not limited to: clinical protocols and amendments, investigator’s brochures (ibs), and clinical study reports (csrs)• ensure a consistent style of presentation of clinical documents to maintain quality and ease of review, and adherence to company standardsglobalchannelmanagement• assist in the development of templates and standard operating procedures (sops)• produce high quality and on-time writing deliverables to support the activities and goals of the clinical study team(s), clinical program, and the medical writing function• regulatory submissions and knowledge of ectd formatting preferred• facilitate efficient review and finalization process of documents produced internally and externally by contractors and vendorscom/jobopenings remote sr• provide quality control (qc) review of clinical regulatory documents, as appropriate• represent medical writing on one or more program teams • participate in medical writing initiatives, and process improvement, as appropriate • collaborate cross-functionally and ensure key messages are consistently aligned in the preparation of clinical regulatory documents

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