Medical writer

• Facilitating the improvement in the overall quality and completeness of provider-based clinical documentation in the medical record
• Assisting treating providers to ensure documentation accurately reflects diagnostic-related group, severity of illness, risk of mortality, risk adjustment, and complexity of patient care rendered
• Conducting accurate and timely concurrent record reviews
• Ensuring data integrity of the clinical documentation database
• Educating customers through presentations and reports on documentation opportunities

RN Clinical Documentation Specialist

• Collaborates with physician, mid-level providers, ancillary staff, and medical records coders to identify principle and secondary diagnoses, and principle procedures
• Reviews for quality indicators
• Conducts initial and ongoing concurrent and some retrospective reviews for system wide admissions for all payors
• Identifies when there is a need to clarify documentation in patient records and initiates queries or communication with providers
• Provides information and education as necessary to providers on an ongoing basis
• Collaborates with Physician Advisor to present education

Clinical Documentation Specialist

• 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)

Medical writer jobs in Arizona

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RN Clinical Documentation Specialist

Clinical Documentation Specialist

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

Medical Writer II – Publications

RN Clinical Documentation Education – Compliance Consultant

Senior Principal Medical Writer – Regulatory Submission Docs, Oncology Preferred