Reporting to our Head of Medical Writing, you will positively impact patients’ when you:

• Review clinical and regulatory documents for high-quality control including: clinical study protocols, protocol amendments, clinical study reports, briefing books, response letters to regulators, and more
• Review all documents for scientific accuracy (citations, reference confirmation), completeness (efficacy, safety, supportive data), high-quality language (articulateness, clarity, grammar, spelling, punctuation) and style according to established internal and external guidelines
• Review all documents for clear and cogent flow and internal consistency in described content. Flag discrepancies to the writer for needed revision or team alignment.
• Ensure that all documents meet industry standards for format, content and sourcing of references
• Collaborate with medical writer leads and their cross-functional stakeholders to help to reconcile diverse feedback if needed via roundtable discussions
• Monitor the status of the circulation of each document across cross-functional reviewers on behalf of the medical writing team. Contribute reporting and status updates at weekly medical writing team meetings.
• Work with program management for key documents to ensure alignment with objective, intended audience and deadlines
• Become an expert in Veeva Vault implementation within Karyopharm as our collaborative authoring platform and generate reports and audits on document review and approval status
• Support internal medical writing team organization with reference libraries, internal tools and platforms, and ensure consistency in approach across all writers

• Bachelor’s degree in a scientific discipline
• 5+ years of industry experience as medical editor or medical publications
• Prior experience at a clinical-stage or commercial-stage pharmaceutical company
• Previous oncology experience preferred.
• Experience with medical writing for NDA, IND, and MAA submissions
• Familiar with Veeva, Documentum, or other collaborative authoring software platforms
• Understanding of industry guidelines
• Detail and process oriented

At Karyopharm, we live and demonstrate our ICARE values every day!

If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That’s why we’ve built an environment centered around support, flexibility, and a shared mission.

Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us – whether that’s onsite, from home, or anywhere in between.

What do you get when you pair an extraordinary mission with a culture of flexibility and empowerment? We invite you to find out and join us on this incredible mission.

Check out our Culture Video!

What We Offer:

In addition to our exciting, supportive, and intellectually challenging global workspaces(s), teamembers enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.

• A culture of employee engagement, diversity, and inclusion
• Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!
• Peace of mind through best in class medical (deducible paid by KPTI), 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 – we encourage you to recharge and spend time with family and friends.
• Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development & mentoring programs, and a variety of reward and recognition programs)
• In the U.S., the salary range for this position is $115,000 to $130,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors
• Cell phone allowance