Role: Senior Medical Writer supporting Viking Therapeutics' clinical development through authoring and reviewing regulatory and clinical documents. Responsibilities produce protocols, clinical study reports, investigator brochures, informed consent forms, safety reports, and regulatory submission sections coordinate with cross-functional teams and external vendors ensure compliance with GxP, ICH-GCP, and regulatory standards manage document timelines and review processes contribute to process improvements Requirements Bachelor's in life sciences or related field with 4+ years' relevant experience or advanced degree with equivalent expertise proven track record in clinical and regulatory document authoring within a GCP environment strong knowledge of ICH-GCP, CTD/eCTD frameworks, and regulatory expectations for clinical documentation excellent scientific writing skills and proficiency with MS Word, document management, and literature tools Preferred experience in metabolic, endocrine, or obesity/GLP-1 therapeutic areas, and outsourcing to CROs HighValue experience in metabolic/endocrine research, regulatory submission work, and managing cross-functional and external collaborations WorkSetup: Details not specified; likely hybrid or office-based. #J-18808-Ljbffr
Computer Systems Analyst Duration: Permanent/Full Time 40 hours per week Pay/Salary: $141,336.00 year Location: EZ4 Technologies LLC, 3174 Ridge Road, Suite #280, Mckinney, TX 75070 Job Duties Details of job duties are not provided.
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