• Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies • May serve as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs • Provides senior level review of routine and complex documents • Provides training and mentorship for other writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge • Ensures compliance with quality processes and requirements for assigned documents • As the subject matter expert, develops and reviews best practices, methods, and techniques for achieving optimal results, including various client-specific processes, and leads process improvement initiatives • May also develop, review, and manage performance metrics for assigned projects • Represents the department at project launch meetings, review meetings, and project team meetings

Role Description BJC is hiring for a Clinical Documentation Coordinator. This role is responsible for reviewing medical records or reports, using Excel to create reports. Must have Epic, Excel, and report writing experience. This is a remote position. Responsibilities - Reviews and audits medical record documentation against Federal and State regulatory compliance requirements. - Accurately collects and compiles data in support of regulatory survey action plans, hospital audit requirements, and any clinical documentation related requests for information for executive level reporting to BJC System committees, BJC reporting dashboards, BJC & HSO Regulatory Committees, etc. - Assists Clinical Documentation Specialists in ensuring the integrity of the medical record accurately reflects clinical documentation has been thoroughly and timely recorded. - Maintains and collaborates to complete collection of clinical documentation data to support timely reporting to Regulatory Teams, Hospital Leadership and other applicable teams focused on ensuring compliant clinical documentation. Qualifications - High School Diploma or GED - Experience: Less than 2 years Preferred Qualifications - Education: Associate or Trade School Equivalent - Experience: 2-5 years - Licenses & Certifications: Registered Health Info Tech Benefits - Comprehensive medical, dental, vision, life insurance, and legal services available first day of the month after hire date - Disability insurance paid for by BJC - Annual 4% BJC Automatic Retirement Contribution - 401(k) plan with BJC match - Tuition Assistance available on first day - BJC Institute for Learning and Development - Health Care and Dependent Care Flexible Spending Accounts - Paid Time Off benefit combines vacation, sick days, holidays and personal time - Adoption assistance

• leading the development of high-quality and on-time clinical study documents • clinical document planning, writing, editing/formatting, and performing QC review • develops documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements • ensures smooth and effective document management from start to finish (ie, from template to final, approved version) • ability to independently formulate key messages from clinical study data • contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents • performing literature-based research to support writing activities

• Conduct detailed home health and hospice pre-billing reviews to support Portfolio partners and their agencies. • Identify discrepancies, missing information, and opportunities for documentation improvement. • Utilize information gathered to provide education and facilitate alterations to the HCHB documentation, and process improvements to prevent recurrence. • Direct agencies to use documentation data outcomes for QA improvements. • Ensure documentation accurately reflects the patient’s clinical status and the care provided. • Set up meetings with clinical leaders to provide education, highlight findings, and make documentation recommendations. • Stay current with practices in both home health and hospice fields and suggest educational and resource materials which would be beneficial to the staff. • Recommend new approaches to on-going continued improvements to policies, procedures, and documentation. • Identify trending issues and share them with the team and the clinical leaders. • Stay up to date with all federal, state, and local regulations, as well as organizational policies and procedures to ensure compliance. • Work within and be comfortable with HCHB, PDF-Xchange, Excel, and Smartsheet.