Remote Sr. Medical Writer Consultant (Irvine, CA)

Remote Sr. Medical Writer Consultant

jobs(at)globalchannelmanagement.coms www.globalchannelmanagement.com jobopeningsRemote Sr. Medical Writer Consultant needs 5 years medical writing experience in clinical development function at a pharmaceutical company or CRO Remote Sr. Medical Writer Consultant requires Strong written and verbal communication skills including fluency in oral and written English with the ability to clearly present clinical data. Regulatory submissions and knowledge of eCTD formatting preferred. Bachelor s degree in a relevant scientific field is required advanced degree preferred. Remote Sr. Medical 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). Provide quality control (QC) review of clinical regulatory documents as appropriate. 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. Ensure a consistent style of presentation of clinical documents to maintain quality and ease of review and adherence to company standards. Facilitate efficient review and finalization process of documents produced internally and externally by contractors and vendors. Assist in the development of templates and standard operating procedures (SOPs). 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.