• Provides concurrent and subsequent reviews of the clinical documentation in the medical record using documentation improvement guidelines. Evaluates and identifies gaps in clinical documentation that need clarification for accurate code assignment to ensure overall quality and completeness of the record. The key responsibility is to review the chart for information not currently in the chart but supported by clinical indicators; then queries the medical staff when necessary through written or verbal communication to obtain accurate and complete physician documentation that supports the severity of patient illness and risk of mortality. • Performs a thorough chart review to determine the most appropriate principal diagnosis of the patient. • Performs a thorough chart review to identify co-morbidities/complications and documents these appropriately within the concurrent CDS worksheet. • Demonstrates an understanding of the importance of, and makes an effort to capture, all appropriate secondary diagnoses. • Coordinates with coding/HIM/UR and other departments to ensure the coded record reflects the acuity of patients and level of provider care. • Demonstrates creativity and enthusiasm while pursuing the goals of the department and the organization. • Maintains the ability to be flexible and prioritizes daily responsibilities. • Uses strong and professional communication skills with providers to clarify information in the medical record. Uses appropriate and compliant querying tools (templates) to capture needed documentation. Conducts follow-up on unanswered queries during the patient stay to obtain a response to unanswered queries. • Provides education to physicians on the importance of complete documentation and key documentation concepts during regular physician meetings or individually with physicians. • Reviews the progress of the CDI program by interpreting performance, process, and quality ratings reports. Identifies areas of focus through report analysis. • Experience with CDI for Peds, Neonatal, and OB.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Director, Medical Writing will take lead in preparation of different types of clinical and regulatory documents and will oversee the writing of clinical documentation in support of clinical development (e.g., protocols, IBs, CSRs, etc.) and regulatory filings (e.g., clinical modules in IND and NDA). They will mentor other medical writers, drive key operational workstreams, ensure all documents adhere to established program strategy, and provide key recommendations for improved outcomes. - Write or supervise writing of complex clinical study−related documents, including protocols, protocol amendments, Investigator Brochures and clinical study reports to support Karyopharm clinical development programs. - Write or supervise writing of regulatory documents including health authority meeting requests, briefing books, regulatory filings including NDA, IND, and Assessment Aids for submissions, where applicable. - Ensure all content is high-quality and consistent with program strategy, and provide recommendations for content enhancements and optimization for team consideration. - Adjudicate cross-functional feedback, drive consensus, and reconcile diverse viewpoints via stakeholder management and facilitating comment resolution forums. - Serve as mentor to other medical writers and leverage prior experience to help build capabilities and co-develop junior talent. - Champion and lead operational workstreams as subject-matter expert to develop new internal guidance and improved practices for other medical writers. - Work with the Head of Medical Writing to develop medical writing processes, standards, and innovative initiatives. - Work in a collaborative manner with team members from various functional groups. - Solve problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve. - Coordinate review and approval of oncologic clinical study-related documents. - Contribute to creation and maintenance of templates and standard text for clinical documents. - Significantly contribute to discussions regarding document content, informed by review of pertinent publications, guidance and/or discussions with outside experts. Qualifications - More than 7 years of Medical Writing experience with evidence of increasing responsibility/technical development. - Experience writing Clinical Overviews and Integrated Summary of Safety/Efficacy in BLA/NDA submissions to Health Authorities. - Experience in managing medical writers preferred. - Knowledge of regulations relevant to medical writing within oncology. - B.S. or equivalent degree in a scientific area. Advanced degree (MS or PhD) preferred. - Ability to assess workload and suggest prioritization to senior staff. - Demonstrated abilities in collaboration with others and independent thought. - Proficient in use of Microsoft Word, Adobe Acrobat, Microsoft PowerPoint and document reviewing software. - Ability to work on several projects in parallel balancing multiple and overlapping timelines. - Careful attention to detail and accuracy. - Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally. Benefits - Comprehensive benefits (medical, dental, vision, 401(k), and more). - Equity and the potential to receive annual target bonuses. - Base salary range for this position is $200 K – $220 K USD. - Peace of mind through best in class medical, dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), ESPP and tuition reimbursement. - Wellness Program with a monthly stipend. - Generous PTO and Holidays. - Ample opportunities to learn and take on new responsibilities in a fast-paced, patient-focused company. - Cell phone allowance.

• Compiles, writes, edits, and coordinates medical writing deliverables • Completes various documents including clinical study protocols • Adheres to established regulatory standards • Coordinates quality and editorial reviews • Acts as peer reviewer for internal team

• Provides onsite and remote clinical documentation integrity (CDI) support to the Health Ministry (HM) CDI programs as part of the System Office CDI Float Pool. • Utilizes advanced coding and/or clinical expertise to direct efforts toward the improvement and integrity of clinical documentation. • Responsible for reviewing and/or auditing medical record clinical documentation to support the medical necessity, severity of illness, risk of mortality, accurate coding, clinical evidence, resources consumed, and level of services rendered to all patients. • Audits HM CDSs for query compliance, workflow and missed documentation opportunities. • Trains end users in the use of CDI system software, standards, and workflow. • Conducts clinical documentation chart reviews and queries providers as appropriate to support RHMs staffing needs. • Follows HM CDI Program workflow and processes and communicates with local CDI Team to support local operations. • Provides documentation education to providers and members of healthcare team at the RHM as part of CDI Team assignment or as requested. • Assists the System Office Clinical Documentation Manager with all aspects of the CDI program across the system including data collection and maintenance of the CDI Dashboard. • Performs other duties as assigned by leadership.