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

• Facilitate improvement system-wide in the overall quality, completeness, and accuracy of the medical record documentation through extensive audit investigation, education and data analysis
• Responsible for identification of patterns, trends, and opportunities for the entire CDI team, at all acute care facilities, to improve accuracy and outcomes
• Responsible for assisting with large retrospective audits, at the request of hospital clients system-wide, and for educating physicians, if needed
• Audits case reviews and queries of Clinical Documentation Specialists (CDIS) to ensure quality and compliance, using audit tools developed
• Tracks, trends, and reports audit findings for each Clinical Documentation Specialist (CDIS), Hospital Region, and System-wide to Director/management team
• Identifies knowledge gaps and provides clear explanations and interpretations on missing, unclear, conflicting, or non-compliant information captured by the CDIS
• Researches, investigates and remains up to date on both clinical and coding guidelines in quarterly Coding Clinics as they relate to physician documentation improvement needed, in an ICD-10 coding environment
• Assists in overall quality, timeliness and completeness of the quality health record to ensure appropriate data, provider communication, and quality outcomes
• Serves as a resource for appropriate clinical documentation
• Develops presentation material and provides training and education to physicians and CDIS staff as needed in an effort to strengthen documentation practices and ensure accurate coding that reflects the severity of illness (SOI) and risk of mortality (ROM) of patients they serve
• Responsible for using audit tools to conduct clinical quality audits
• Develops and updates policies and procedures around the CDIS audit function; and refines audit tools as needed in collaboration with Director/management team
• Collaborates with leadership to conduct focused post-discharge documentation and coding audits as requested by hospital clients system-wide
• Ensures safe care to patients, staff and visitors; adheres to all Memorial Hermann policies, procedures, and standards within budgetary specifications including time management, supply management, productivity and quality of service
• Promotes individual professional growth and development by meeting requirements for mandatory/continuing education and skills competency; supports department-based goals which contribute to the success of the organization; serves as preceptor, mentor and resource to less experienced staff
• Demonstrates commitment to caring for every member of our community by creating compassionate and personalized experiences
• Models Memorial Hermann’s service standards by providing safe, caring, personalized and efficient experiences to patients and colleagues

Clinical Documentation Auditor – Educator

• 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

• The Director of Clinical Documentation Integrity demonstrates a high level of clinical proficiency and critical thinking skills necessary for oversight and success of the CDI solution.
• Works collaboratively with Guidehouse and facility CDI leadership team to meet contractual obligations, achieve best practice CDI metrics and assist in meeting overall organizational goals related to documentation improvement.
• Must demonstrate ability to design and manage process and workflow improvements, system implementations and project management.
• Will assist in analyzing, tracking, trending and reporting CDI and/or organizational data and metrics.
• Collaborate extensively and in a collegial manner with Physician Advisors, Chief Medical Officer (CMO), Chief Quality Officers (CQO’s), other key providers and client site Department leaders.
• Actively participates on committees and presents at the monthly revenue cycle meetings to demonstrate solution performance and improvement in clinical documentation.

Director of Clinical Documentation Integrity

• Performs concurrent analytical reviews of clinical and coding data to improving physician documentation for all conditions and treatments from point of entry to discharge.
• Facilitates the resolution of queries and educates members of the patient care team regarding documentation guidelines.
• Collaborates with coding professionals to ensure accuracy of diagnostic and procedural data.
• Completes initial reviews of patient records and evaluates documentation to assign the principal diagnosis.
• Maintains appropriate productivity level.
• Conducts follow-up reviews of patients to assign a working or final DRG assignment upon patient discharge.
• Queries physicians regarding missing, unclear, or conflicting health record documentation.
• Identifies issues with reporting of diagnostic testing proactively.
• Enhances expertise in query development, presentation, and standards.
• Educates physicians and key healthcare providers regarding clinical documentation improvement.
• Attends department meetings to review documentation related issues.
• Conducts independent research to promote knowledge of clinical topics and coding guidelines.
• Collaborates with coding to reconcile the DRG and resolves mismatches.

Clinical Documentation Specialist, First Reviewer

• Support all care teams across the region in comprehensive and targeted chart reviews
• Partner with regional leaders on workflow optimization
• Access and review HIE/EMRs to identify potential suspects based on test results
• Identify the need for Medical Records requests
• Prepare and lead monthly Rejected Suspect Reviews
• Identify and analyze opportunities for improving patient quality outcomes and cost of care
• Monitor clinical documentation efforts
• Other duties, as assigned

Senior Clinical Documentation Specialist

• Improves the accuracy and completeness of clinical documentation in medical records
• Performs thorough reviews and requests clarifications from clinicians
• Facilitates modifications that accurately reflect patient severity, risk, and resource use
• Collaborates with clinicians and coders
• Ensures compliance with regulatory guidelines
• Supports accurate reporting of provider and hospital outcomes
• Actively contributes to operational improvements
• Participates in education and program-related activities

Clinical Documentation Specialist

• Performs initial case reviews and an appropriate number of follow-up reviews based on program standards. Uses clinical insight and judgment of clinical findings to assess clinical documentation for improvement opportunities. Independently develops complex queries.
• Maintains query rate, response rate, and agreement rate in line with established performance benchmarks.
• Assists with reviewing records at different Inova hospitals as needed and under the supervision of assigned CDI leaders.
• Participates in all department-wide CDI and coding education on ICD-10, MS-DRG, and quality outcome measures as well as compliance requirements related to query (AHIMA Practice brief).
• Maintains competency in the use of CDI applications to process daily work lists and report results of record reviews and queries.
• Enters all required data into CDI applications to enable Coding professionals and Coding Quality Coordinators to determine the disposition of concurrent queries in order to assign the final MS-DRG as well as APR-DRG, SOI, and ROM and risk adjustment factors.
• Demonstrates expert knowledge of ICD 10 codes and MS-DRG/APR DRG assignments.
• Interacts with Coding Quality Coordinators and Coding professionals on any questions related to CDI working DRG related to concurrent queries and final coding.
• Assists with any post-discharge (retrospective) queries per CDI policy/procedure and as requested by CDI leadership.
• Demonstrates advanced technical ability with current software used by the department.
• Provides electronic support to providers regarding best practice documentation standards and the query process. Provides 1:1 provider education within the daily workflow and participates in group education sessions as requested by CDI Leadership.
• Participates in special projects, audits, and other duties as directed by CDI Leadership. May assist with precepting and education of new staff.
• Works collaboratively with medical, nursing, and ancillary staff to improve the quality of chart documentation that assures appropriate DRG classification to accurately reflect patient severity of illness and risk of mortality.
• Participates, and takes a leadership role in, select special projects, audits, and other duties as directed by CDI Leadership.
• As needed, may travel across the Washington DC metro area to engage with providers.
• May perform additional duties as assigned.

Clinical Documentation Integrity Specialist

• The Clinical Documentation Integrity Specialist (CDIS) Lead is an advanced level position for the experienced and proficient CDI Specialist consistently meeting or exceeding all criteria for CDIS advanced performance.
• The CDIS Lead provides support to CDI leadership within a defined scope of facilities and CDI team.
• The CDIS Lead serves as a liaison between senior leadership, medical staff, nursing, coding, case management and quality departments.
• Key Responsibilities: May be assigned special projects related to CDI processes, quality, data analysis, or HIM/CDI performance.
• Assumes responsibility for daily workflow process and adjustments for the CDI team.
• May present CDI performance metrics at facility meetings.
• May present CDI education as needed.
• Will assume operational oversight in the absence of the CDI Director.
• Supports CDI team through multidisciplinary approach in support of program goals.
• Facilitates collaborative efforts between CDI, HIM and Medical Staff providers.
• Facilitates collaborative efforts between CDI and clinical teams such as Quality and Case Management.
• Effectively utilizes leadership abilities and critical thinking skills to identify opportunities for team process and engagement optimization.
• Maintains professional competency in documentation and coding practices by keeping up to date with new coding guidelines, policies/procedures, federal and state reimbursement.

Clinical Documentation Integrity Specialist – Lead

• Assists with the appropriate identification of diagnoses, conditions, and/or procedures that are representative of the patient’s hospital stay and care provided
• Initiates concurrent queries to providers as supported by medical record documentation to improve the accuracy, integrity, and quality of patient data
• Reviews inpatient records to ensure completeness, accuracy, and clinical validation
• Evaluates documentation for assignment of working and possible DRG
• Recognizes opportunities for documentation improvement
• Identifies opportunities to query physicians regarding missing, unclear, or conflicting documentation
• Interacts directly with physicians to request and obtain additional documentation when needed
• Facilitates modifications to physician documentation to reflect the complexity of care of the patient
• Collaborates with and educates members of the patient care team regarding documentation guidelines

Clinical Documentation Specialist I – CDI

• The Clinical Documentation Specialist facilitates improvement in the overall quality, completeness and accuracy of medical records documentation.
• Reviews and recommends opportunities for documentation improvement through extensive record review.
• Obtains appropriate clinical documentation through extensive interaction with physicians, patient care providers and the coding team to ensure the clinical documentation reflects the level of service rendered to the patient is complete and accurate.
• Educates members of the patient care team regarding documentation guidelines on an ongoing basis.
• Demonstrates knowledge and skills necessary to assign an accurate severity of illness.

Nurse Clinical Documentation Specialist

• 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

• Write, edit, and manage manuscripts, posters, abstracts, oral presentation slide decks, and review articles, on time, within budget, and with little instruction
• Raise and help resolve project management issues, such as out-of-scope requests
• Ensure compliance with quality processes and industry standards
• Represent the team as the lead contact on projects
• Lead or provide input on process improvements

Senior Medical Writer, Publications

• Responsible for CDI query reconciliation accuracy
• Compiling and generating key performance metrics for entities such as physicians, providers, CDI team and facility leadership after review with CDI Leadership
• Participate on multi-disciplinary enterprise quality and process improvement teams
• Collaborate with CDI Auditor/Educators to develop and implement programs for ongoing CDI, physicians, providers, and ancillary departmental education
• Evaluate opportunities for new CDI initiatives via ongoing metric analysis including validating workflows, tracking, and trending of results
• Perform other duties as assigned

Clinical Documentation Integrity Nurse – Data Analytics

• Provide education to providers and clinicians for accurate clinical documentation
• Review for correct DRG, APC, and HCC assignment
• Adhere to industry standards for documentation and coding compliance
• Maintain a record of review and query activity in CDI software
• Conduct reviews of medical records in outpatient settings
• Educate providers on optimal documentation and coding

• Responsible for providing expertise to support the development of clinical and regulatory documents
• Mentor Medical Writers as needed
• Manage document writing tasks and ensure compliance with regulatory guidelines
• Navigate through uncertainties to manage timelines for multiple documents
• Identify risks and develop mitigation plans
• Contribute to process/tool optimization and establishment
• Lead training programs and mentorship for Medical Writers

Senior Principal Medical Writer

• Provides expertise to support the development of high-quality clinical and regulatory documents
• Manages assigned writing tasks ensuring adherence to regulatory guidelines
• Navigates uncertainties to develop and manage timelines of individual and multiple documents
• Identifies needs for process/tool optimization and proposes solutions
• Leads development of new training programs for junior MWs

Principal Medical Writer

• Review, analyze and code diagnostic information in patient charts; identify coding opportunities for improved coding accuracy
• Validate missed coding opportunities
• Ensure compliance with established coding guidelines, third party reimbursement policies, regulations and accreditation guidelines
• Audit patient charts to ensure accurate coding

Clinical Documentation Coder

• Develop scientific copy for various deliverables on assigned brands and products
• Work independently and collaboratively with medical writers and directors to develop scientifically accurate copy
• Understand medical strategy and content objectives for assigned projects and accounts
• Proactively check-in with senior medical leads on project deliverables and raise questions as needed
• Review current literature for assigned therapeutics areas, including competitor products
• Understand and adhere to AMA/client style guidelines as directed
• Ensure references are accurate and research additional references or source materials as necessary
• Annotate and highlight references for medical review
• Manage workflow for assigned projects and meet associated deadlines
• Communicate with clients and/or KOLs to present scientific projects for review and feedback
• Incorporate and discuss edits requested by clients, KOLs, and/or internal reviewers
• Attend and participate in kickoff, status, and other job-related meetings
• Collaborate with creative and illustrative team members to make scientific data visually compelling and scientifically accurate
• Provide medical guidance to team by maintaining up to date scientific knowledge for assigned brands and products

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

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Senior Principal Medical Writer – Regulatory Submission Docs, Oncology Preferred

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