• Oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations • Lead the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity • Collaborate with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development • Provide guidance on best practices for medical writing and ensure adherence to regulatory requirements and internal standards • Mentor and train junior medical writers, fostering a culture of excellence and professional growth • Stay current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs • Act as a lead medical writer for complex projects and lead clinical/regulatory marketing approval applications for new biologics and drugs

• Translate complex benefit information, including non-standard plan language into crisp, compliant, easy-to-understand plan language for self-funded plans • Analyze, draft, edit and review all legal and regulatory plan documentation for self-funded plan customers • Ensure the plan and company remain in compliance with federal and state law • Deliver high-quality documentation ensuring department standards are met

Role Description The Lead Clinical Documentation Department Improvement Specialist is a certified coder with a high level of clinical proficiency necessary for leadership of the Clinical Documentation team of licensed nurses and certified coders. Oversees the review processes of complex pediatric patients in accordance with all current payer initiatives and development in acute and chronic disease states. - Understands a wide range of specialized disciplines, including education in anatomy and physiology, pathophysiology, and pharmacology. - Knowledge of official medical coding guidelines, CMS, and private payer regulations related to the Inpatient Prospective Payment System. - Ability to analyze and interpret medical record documentation and formulate appropriate physician queries. - Ability to benchmark and assist in analyzing clinical documentation program performance. - Exhibits sufficient knowledge of clinical documentation, coding, reporting requirements, APR-DRG assignment, and clinical conditions or procedures impacting severity of illness, risk of mortality, and/or data quality. - Facilitates complete and accurate documentation and coding of inpatient medical records on a concurrent and retrospective basis. - Serves as a resource for HIM coders and physicians regarding proper documentation practices and the link to ICD-10 codes and APR-DRG assignments. - Collaborates with interdisciplinary teams including physicians, nurse practitioners, PA's, Quality, Case Management, Risk Management, Health Information Management/Coding, Decision Support, product vendors, and other members of the health care team. - Involved in the direction and education of all phases of the Clinical Documentation process. - Requires knowledge and leadership of the day-to-day processes of the Clinical Documentation team including workflow and training needs. - Assists management with providing ongoing Clinical Documentation education for current and new staff. - Maintains professional development by participating in workshops, conferences, and/or in-services. Qualifications - Must maintain current knowledge of reimbursement systems and federal, state and payer-specific regulations and policies. - Must demonstrate continuing education in CDI, inpatient coding, and/or reporting compliance areas. - Certificates, Licenses, Registrations: RHIA, RHIT, or CCS certification preferred or eligible – to be achieved within 2 years of employment. - CDIP or CCDS certification preferred or eligible – to be achieved within 3 years of employment. Requirements - Always maintains utmost level of confidentiality and integrity. - Adheres to hospital policies and procedures. - Demonstrates business practices and personal actions that are ethical and adhere to corporate compliance and integrity guidelines. - Serves as a subject matter expert for the CDI program, inpatient coding, and reimbursement methodologies. - Demonstrates ability to educate medical and hospital staff regarding the MS-DRG and APR-DRG reimbursement methodologies. - Assists HIM management with coordination of CDI compliance reviews. - Communicates with hospital personnel regarding questions relevant to CDI, inpatient coding, and reimbursement. - Assists HIM management in communicating with physicians and other clinicians concerning opportunities for improvement relevant to clinical documentation and its impact on reporting. - Assists HIM management in the development and maintenance of hospital specific CDI, reporting and billing guidelines. - Attends hospital committee meetings as needed. - Monitors and evaluates case mix patterns and trends. - Reviews and codes inpatient medical records as needed for additional backlog and reporting support. - Assists with special projects as assigned by HIM management. - Completes initial reviews timely in order to promptly identify potential documentation improvement opportunities. - Conducts follow-up reviews of patients as scheduled to support and assign a working or final APR-DRG. - Queries physicians regarding missing, unclear, or conflicting health record documentation. - Educates physicians and key healthcare providers regarding clinical documentation improvement and the need for accurate and complete documentation in the health record. - Collaborates with CDI Physician Champion, case managers, nursing staff, and other ancillary staff regarding interaction with physicians on documentation and to resolve physician queries prior to patient discharge. - Participates in the analysis and trending of statistical data for specified patient populations to identify documentation improvement opportunities. - Assists with preparation and presentation of clinical documentation monitoring/trending reports for review. - Partners with the coding professionals to ensure accuracy of diagnostic and procedural data and completeness of supporting documentation to assign ICD-9-CM and ICD-10-CM/PCS diagnosis and procedure codes to determine an accurate working and final APR-DRG, severity of illness, and/or risk of mortality. - Assists in the appeal process resulting from third-party reviews. - Proficiency in the use of Microsoft applications (e.g. Word, Excel, PowerPoint), Epic, and 3M CRS and 3M CDI 360 Encompass. Benefits

Role Description The Medical Writer (MW) will research, create, and edit all documents associated with clinical research. Responsibilities also include: - Acting as primary client contact for medical writing projects. - Working with other Parexel departments and clients to set and meet internal/external deliverable timelines. - Project leadership and training and support of junior medical writing staff. Key Accountabilities: - Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: - Briefing documents - Investigator brochures - Study protocols - Model informed consents - Interim and final clinical study reports - Common technical document (CTD) clinical overviews and summaries - Safety update/aggregate reports - Integrated summaries of safety and efficacy - Ensure that all work is complete and of high quality prior to team distribution or shipment to the client, including: - Data consistency and integrity - Publishing readiness - Adherence to regulatory guidelines - Compliance with departmental, corporate or client SOPs - Act as project manager/lead for medical writing projects, which may entail: - Serving as the primary client contact - Negotiating deliverable timelines - Resolving project-related issues - Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership, including: - Communicating content requirements - Coordinating and conducting interdepartmental team review of draft and final documents - Scheduling and leading/facilitating authoring team meetings - Evaluating progress on tasks and identifying issues - Managing/Driving the timeline and advancing document development to approval - Distributing final documents to project team and client Qualifications - Excellent interpersonal, verbal, and written communication skills. - Ability to consistently produce documents of high quality. - Demonstrates attention to details and proactivity. - Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. - A flexible attitude with respect to work assignments and new learning; readily adapts to changes. - Ability to efficiently manage time spent on tasks and proactively identify deficiencies. - Competent working in a matrix environment and values the importance of teamwork. - Ability to negotiate on behalf of medical writing to ensure resources, timelines, and expectations are aligned. - Understands and satisfies client needs. - Gains trust and establishes a connection with the client beyond one's project. - Provides departmental expertise and perspectives to promote prospective business opportunities. Requirements - Japanese periodic safety report (especially DSUR annex format and unknown non-serious adverse event report) creation experience of 1 year or more. - Medical writing experience of 3 years or more. - Business-level English proficiency. Benefits - Ability to leverage English skills in a global environment. - Opportunity to enhance expertise in the area of safety reports. - Contribute to regulatory submissions through the creation of important documents in drug development. - Flexible working environment.