Karyopharm Therapeutics

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.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The GMSA intern will play a key role in assisting with the maintenance and updating of all field medical materials employed by the MSLs. This will require continuous interaction with the National Field Director and Director of Medical Communications to ensure relevant decks and materials are updated and expiring materials reapproved. All necessary updates to decks and other materials will be made by the intern and vetted with the Director of Medical Communications/National Field Director. Once necessary changes/updates are made and approved, the intern will be responsible for shepherding the updated material through the Veeva Medical Communications and MMRT approval process. As a contributing member of the GMSA team, the intern will also be required to attend Medical Communication meetings with relevant vendors and attend all internal Medical Communication meetings. - Learn all relevant aspects of Veeva Medical Communications - Maintain and update all field medical materials - Shepherd all newly updated medical material through the approval process - Provide assistance to members of the Medical Communications team on additional projects when needed - Attend all relevant internal Medical Communications meetings and those with vendors - Ensure that all expiring field medical material are resubmitted in Veeva Medical Communications for reapproval The intern will meet every week with the Director of Medical Communications to review progress and ensure aims of the internship are being met. Qualifications - Currently enrolled in a PharmD or PhD program - Area of study should be in a business, marketing, healthcare, or biomedical sciences related focus with an interest in a career in the medical or biotech field - A solid foundation of general experience with both PowerPoint and Excel - Ability to support all time zones in which leadership team resides (US Only) - Virtually meeting skill sets and the ability to complete projects with minimal supervision Requirements - Must be able to complete the Karyopharm Internship Program from 26 May – 07 Aug 2026 - Currently enrolled high school or college (bachelor’s program) student - Student must be returning to school in the Fall Term - Must have a minimum GPA of 3.0 - Must be highly organized and have the ability to work independently and collaboratively as a team - Clear, concise verbal & written communication Benefits - Pay for internships ranges from $22 to $30 per hour, depending on the student's academic level (e.g., Bachelor's, Master's) and year in school Company Description At Karyopharm, we live and demonstrate our ICARE values every day! Check out our Culture Video!