Medical writer

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and the client authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.
• Participate in cross-functional process improvement initiatives.
• Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
• Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
• Mentor more junior medical writing staff.

Senior Principal Medical Writer – Regulatory Submission Docs, ISE/ISS/Clinical Overview, Oncology Preferred

• 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.
• Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings.
• Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget.
• 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.
• Provides feedback to further define statistical output required and document needs.
• Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables.
• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.

Medical Writer II – Publications

• Deliver formal education to staff and providers
• Develop impactful learning modules
• Conduct audits to ensure accuracy and continuous improvement
• Assist with onboarding new hires
• Provide ongoing, continuing education and competency assessments
• Perform concurrent, retrospective, and secondary clinical chart reviews

RN Clinical Documentation Education – Compliance Consultant

• Develop regulatory documents for submission to regulatory agencies globally
• Manage medical writing projects, including developing timelines
• Participate in cross-functional meetings to provide input regarding medical writing deliverables
• Review other documents associated with the assigned project(s)

Senior Principal Medical Writer – Regulatory Submission Docs, Oncology Preferred

• Applies clinical expertise and knowledge of health care workflows in order to educate and train CDI Specialists in the essential duties of their role to improve the overall accuracy and comprehensiveness of medical record documentation, with focus on ensuring accurate reporting of quality outcomes
• Educates CDI Specialists on the rules/regulations associated with coding and clinical documentation integrity.
• Trains newly hired CDI Specialists and provides ongoing coaching and education specific to daily CDI Specialist job functions.
• Ensures the work output of the Clinical Documentation Integrity staff is accurate and compliant.
• Collaborates with CDI leadership and Coding team to identify training opportunities and assist with education of CDI and Coding staff with regard to clinical documentation integrity and/or clinical and coding scenarios as needed.
• Performs post-discharge, final coded, pre-bill reviews of targeted records identified for second-level review for opportunity to accurately capture patient acuity, severity of illness, risk of mortality, and DRG assignment in compliance with industry rules and regulations.
• Documents SLR findings within CDI application.
• If a documentation opportunity is identified, place physician query and follow up for response to ensure completeness and accuracy of the medical record.
• If coding opportunity is identified, coordinate with coder and/or Coding Leadership to review and address opportunity as applicable.
• Serves as a role model and resource for CDI team members.
• Subject matter expert that exhibits excellent skills in essential components of the CDI Specialist role.
• Responds to CDS requests for concurrent chart reviews on challenging cases with recommendations and supporting rationale.
• Performs concurrent second level reviews based on defined criteria and shares feedback with CDI Specialist assigned to the encounter for action on opportunities identified.
• Maintains a summary of opportunities identified through second level review for feedback and education with the CDI team.
• Coordinates with other Second Level Reviewers, CDI Leads, and CDI Educator to compile trends and areas of opportunity and conduct education both 1:1 and group education with the CDI team based on the findings.
• Periodically review the criteria established for cases triggering a second level review and recommend updates or modifications to the criteria to assist in identifying areas of opportunity.
• Is actively engaged in quality and process improvement efforts.
• Performs targeted audits as assigned in support of department initiatives.
• Participates in quality initiatives such as HAC/PSI and US News/Mortality.
• Collaborates with CDI Leadership, Leads and Educators to optimize query templates.
• Identifies and shares feedback regarding workflow improvement opportunities identified when completing the SLR process.
• Facilitates change and supports the CDI team through change management processes.
• Actively engages in advancing the CDI practice throughout the UH enterprise.
• Actively engages in department and/or enterprise-wide committee.
• Performs other duties as assigned. Complies with all policies and standards. For specific duties and responsibilities, refer to documentation provided by the department during orientation.

Clinical Documentation Integrity Analyst

• Serve as an advisor and expert resource for providers to improve the accuracy of clinical documentation to support patient complexity, risk profiles and appropriate E/M levels
• Assist providers in identifying clinically relevant information and capturing the clinical documentation needed to accurately reflect patient acuity
• Focus on the recapture and identification of chronic conditions reflected in Hierarchical Condition Categories (HCCs)
• Complete pre-visit and post-claim reviews as well as providing clear communication and education to providers on their documentation, coding and billing practices
• Coordinate with colleagues from the CDI Program or other members of the organization regarding education and training geared towards improving clinical documentation

Clinical Documentation Specialist

• Ensures documentation is accurate and complete by performing timely medical record review and determination of code assignment by applying clinical and/or coding expertise to identify opportunities for improved or clarified documentation that accurately reflects the patient.
• Direct and timely follow-up with clinical providers to ensure requested clarification is provided.
• Responsible and accountable for expanding CDI and coding knowledge (keeping up to date on latest research, technology, treatment modalities, etc.)
• Actively engages in educating physicians and other clinical care providers regarding clinical documentation in a variety of formats including participation in clinical rounding, service line focused education sessions and one to one case specific feedback.
• Applies knowledge of health care workflows in order to work collaboratively with medical staff and other health care team members to improve the overall accuracy and comprehensiveness of medical record documentation, with focus on ensuring accurate reporting of quality outcomes.
• Meets established operational and productivity standards. Consistently meets productivity, quality, and AHIMA ethical standards.

Clinical Documentation Integrity Specialist

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• 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
• Completes a variety of documents that may include clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts
• Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures
• 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
• Provides feedback to further define statistical output required and document needs
• Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs as necessary
• Performs online clinical literature searches and complies with copyright requirements
• Identifies and proposes solutions to resolve issues, escalating as appropriate
• Provides technical support, training, and consultation to department and other company staff
• Mentors and leads less experienced medical writers on complex projects, as necessary

Principal Medical Writer – Publications

• The Advanced Practice Safety & Quality Clinical Documentation Integrity (CDI) APP plays a critical role in strengthening the accuracy, clarity, and completeness of the clinical record.
• This position directly supports organizational priorities in quality outcomes, patient safety, financial stewardship, regulatory compliance, and national ranking performance by ensuring that documentation accurately represents each patient's true clinical picture.
• High‑quality documentation is essential for reflecting actual patient acuity, capturing comorbid conditions, describing clinical complexity, and demonstrating the intensity of services delivered.
• Precise documentation contributes to the reliability of key performance metrics, including mortality index, complication rates, length‑of‑stay efficiency, readmission calculations, and CMS quality programs, so the care provided is evaluated fairly and transparently.
• By applying advanced clinical knowledge, critical thinking, and real‑time insight into patient care, the APP in this role ensures that documentation aligns with clinical reality.
• This includes recognizing missing or unclear elements in provider notes, identifying clinical indicators that support diagnoses, ensuring treatment plans are documented in a way that reflects decision‑making, and validating that severity‑of‑illness and resource utilization are fully captured.
• This APP also helps prevent documentation gaps that can affect coding accuracy, billing compliance, audit risk, and institutional financial performance.
• The role strengthens the integrity of the medical record by ensuring that documentation: Clearly describes differential diagnosis and diagnostic reasoning, Accurately captures evolving acuity, organ dysfunction, and clinical complexity, Reflects complications, comorbidities, and risk factors supported by clinical evidence, Documents the rationale behind testing, monitoring, and therapeutic intensity, Aligns with coding guidelines and supports complete, accurate code assignment.
• Through consistent involvement in documentation review processes and collaboration with clinicians, coding professionals, quality teams, and CDI specialists, this APP helps ensure that the medical record serves as an accurate and reliable representation of the patient’s condition and the care delivered.

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