• responsible for concurrent review of inpatient medical records to identify opportunities for improving the quality of medical record documentation. • confer with the appropriate caregiver on the additional documentation that may be required. • achieve a complete medical record by the time of patient discharge in order to ensure quality documentation that reflect the patients’ diagnoses, treatments, and severity of illness. • facilitate and enhance the coding and DRG assignment process. • supports initiatives to improve the quality of documentation by all caregivers within the Ohio State University Health System with specific emphasis on improving documentation to support the coding process which ultimately improves the organization’s performance on quality measures and on the Case Mix Index (CMI).

• Audit, edit, and maintain clinical and regulatory documents, including Clinical Evaluation Reports (CERs), Clinical Study Protocols and Reports (CSPs/CSRs), Investigator’s Brochures (IBs), IFUs, Post-Market Clinical Follow-up (PMCF) plans and reports, and risk management documentation. Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MDR, and EU and FDA guidance documents) and applicable Pulse Biosciences SOPs • Collaborate with Clinical, Regulatory, Quality, Biostatistics and R&D Engineering to ensure aligned messaging and data interpretation • Conduct literature reviews and synthesize clinical data from multiple sources • Review and edit manuscripts for submission and publication in peer-reviewed journals • Translate complex scientific and clinical information into clear, concise and regulatory-compliance narratives • Support document strategy, timelines and regulatory submissions (e.g. FDA, PMA, CE marking technical documentation) • Involved in responses to complex queries such as those issued by notified bodies and stakeholder • Maintain document consistency, version control, and audit readiness • Contribute to SOP development and process improvements

Title: Clinical Document Improvement Specialist Location: Los Angeles United States Job Description: Job Description Join a team that's shaping the future of pediatric care. Children's Hospital Los Angeles is consistently ranked among the top 10 children's hospitals in the nation, delivering world-class care through more than 350 specialized programs and services. Here, world-class experts in medicine, research, and education work together to deliver family-centered care to more than 155,000 patients each year. At CHLA, your work will help build brighter tomorrows for the children and families we serve. Overview This is 100% remote position. CHLA requires a primary residence in California prior to start date. Schedule: Monday-Friday, Day Shift Purpose Statement/Position Summary: The Clinical Documentation Specialist (CDIS) reviews medical records on a concurrent and retrospective basis to improve overall quality and completeness of clinical documentation of patient records. Works collaboratively with clinicians to ensure that clinical information in the medical record is present and accurate and provides training and education as needed. Works with the coding staff to provide guidance to ensure that appropriate clinical severity is captured for the level of service rendered to all patients. The CDIS will also perform focused reviews at the discretion of the Manager. Minimum Qualifications/Work Experience: 3 years of experience in coding, preferably in an academic setting. Demonstrates exceptional coding skills with extensive experience in ICD10. Pediatric experience preferred. Education/Licensure/Certifications: High School Diploma, GED, or equivalent. Current state licensure as coding specialist, registered health information administrator, and/or registered health information technologist. Pay Scale Information $79,934.00-$131,321.00 CHLA values the contribution each Team Member brings to our organization. Final determination of a successful candidate's starting pay will vary based on a number of factors, including, but not limited to, education and experience within the job or the industry. The pay scale listed for this position is generally for candidates who meet the specified qualifications and requirements listed on this specific job description. Additional pay may be determined for those candidates who exceed these specified qualifications and requirements. We provide a competitive compensation package that recognizes your experience, credentials, and education alongside a robust benefits program to meet your needs. About Us CHLA is a leader in pediatric and adolescent health, in our community, across the nation, and around the world . As a premier Magnet-recognized teaching hospital, CHLA offers an environment rooted in learning, collaboration, and compassionate care. . We are home to groundbreaking research, clinical innovation, and a culture that supports personal and professional growth. Since 1932, CHLA has been affiliated with the Keck School of Medicine of the University of Southern California. Through this partnership and our own enduring mission, we remain committed to creating hope and building healthier futures. CHLA is an Equal Opportunity Employer At Children's Hospital Los Angeles, our work matters. And so do each and every one of our valued team members. We consider qualified applicants for all positions without regard to race, color, religion, creed, national origin, sex, gender identity, age, physical or mental disability, sexual orientation, marital status, veteran or military status, genetic information or any other legally protected basis under federal, state or local laws, regulations or ordinances. We will also consider for employment qualified applicants with criminal history, in a manner consistent with the requirements of state and local laws, including the LA City Fair Chance Ordinance and SF Fair Chance Ordinance. Qualified Applicants with disabilities are entitled to reasonable accommodation under the California Fair Employment and Housing Act and the Americans with Disabilities Act. Please contact CHLA Human Resources if you need assistance completing the application process. Our various experiences, perspectives and backgrounds allow us to better serve our patients and create a strong community at CHLA.

Role Description Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client. - Completes a variety of documents that may include: - 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 for scientific meetings - Adheres to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates. - Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. - Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format. - Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency. - Interacts and builds good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs. - Performs online clinical literature searches and complies with copyright requirements. - Identifies and proposes solutions to resolve issues, providing technical support, training, and consultation to department and other company staff. - Mentors and leads less experienced medical writers on complex projects. - Develops deep expertise on key topics in the industry and the regulatory requirements affecting medical writing. - Aware of budget specifications for assigned projects, working within budgeted hours and communicating status and changes to medical writing leadership. - Completes required administrative tasks within specified timeframes. - Performs other work-related duties as assigned. - Minimal travel may be required (less than 25%). Qualifications - 3-5 years of relevant experience in science, technical, or medical writing. - Experience working in the biopharmaceutical, device, or contract research organization industry required. - Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required. - Experience writing relevant document types required. - Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style. Requirements - Ability to work within budgeted hours and communicate status and changes to leadership. - Strong mentoring skills for less experienced medical writers. - Ability to perform online clinical literature searches and comply with copyright requirements. Benefits - Company car or car allowance - Health benefits including Medical, Dental, and Vision - Company match 401k - Eligibility to participate in Employee Stock Purchase Plan - Eligibility to earn commissions/bonus based on company and individual performance - Flexible paid time off (PTO) and sick time Salary Range $80,600.00 - $145,000.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.