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.

• Produces high‑quality promotional content that is scientifically robust, strategically aligned, and brand consistent. • Develops and refines copy for a range of promotional deliverables, including: • Promotional Campaigns • Brand Narratives • Detail Aids (digital and print) • Leave Pieces • Promotional emails • Congress materials (e.g., symposia content, promotional booths, visual messaging) • Claims support materials • Interactive and digital promotional tools • Applies a strong understanding of the ABPI Code of Practice and ensures all materials meet compliance requirements. • Interprets complex scientific data and translates it into clear, credible, and compelling promotional messages. • Conducts targeted literature searches to identify data that strengthen brand messaging, claims, and promotional narratives. • Develops multiple rounds of content with precision, including annotations, references, claims support, and ABPI‑compliant substantiation. • Incorporates internal and client feedback effectively, producing final deliverables that reviewers can trust and progress with confidence. • Ensures brand story arcs and promotional strategy are reflected across all materials. • Collaborates closely with Account, Editorial, Creative, Digital, and Client Services teams to ensure timely, cohesive delivery. • Manages multiple priorities efficiently, delivering work within allocated budgeted hours and communicating proactively around timelines. • Partners effectively with SrScD/ScD, PMWs, Account Directors, and clients to align on brand objectives, data requirements, and communication strategy. • Leads scientific discussions with clients and external experts in calls, meetings, and medical‑legal‑regulatory (MLR) review sessions. • Acts as the scientific lead for assigned brand projects, ensuring clarity in communication and alignment across functions. • Navigates and leads the MLR process confidently, providing scientific justification for claims, responding to review queries, and guiding internal teams on required changes. • Leads assigned brand‑promotion projects from a scientific perspective, ensuring excellence in delivery from concept through to finalisation. • Provides mentorship and first‑pass review support for junior writers. • Works with the SrScD/ScD to enhance processes, improve team efficiency, and uphold best practices for promotional writing. • Supports business development activities with scientific input and contributes to pitches as required. • Stays current with therapeutic landscape developments, regulatory updates, and promotional best practices.