Medical writer

• Facilitate timely and accurate physician documentation in the medical record through concurrent chart review
• Communicate and collaborate with physicians, nursing, ancillary staff, and Health Information Management coders
• Provide ongoing education to the patient care team regarding proper clinical documentation using approved guidelines
• Understand and utilize ICD-10-CM and PCS coding assignments
• Follow Official Coding Guidelines

Clinical Documentation Specialist

• Lead clear and accurate completion of medical writing deliverables
• Manage medical writing activities for individual studies with minimal supervision
• Coordinate medical writing activities within and across departments
• Lead resolution of client comments
• Complete clinical study protocols and amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations
• Adhere to ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides
• Coordinate quality and editorial reviews and manage source documentation
• Lead team document reviews and review documents as needed
• Act as peer reviewer for internal teams
• Review statistical analysis plans and table/figure/listing specifications
• Build working relationships with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
• Perform online clinical literature searches and comply with copyright requirements
• Identify and propose solutions, escalating issues as appropriate
• Provide technical support, training, and consultation
• Contribute to internal materials, presentations, processes, standard practices, and capabilities
• Mentor and lead less experienced medical writers on complex projects
• Develop expertise in industry topics and regulatory requirements
• Monitor project budgets and communicate status and changes to medical writing leadership
• Complete required administrative tasks
• Perform other assigned work-related duties

Medical writer jobs in Missouri

Clinical Documentation Specialist

Senior Medical Writer – Clinical Document Writing