The Director, Global Medical Review, plays a key role in the GMSA Team and is responsible for ensuring medical and scientific accuracy of promotional and non-promotional materials in compliance with US laws and regulations and company policies. The position involves reviewing all materials submitted to the Medical Material Review Team (MMRT) and Commercial Review Committee (CRC) to ensure regulatory and scientific standards are met, while fostering collaboration with Legal and Regulatory teams to maintain compliance and quality. The Director, Medical Reviewer, is also responsible for reviewing all the social media posts, press releases and investor decks for medical and scientific accuracy. In addition, the Director, Medical Reviewer will work with the Medstrat leads on content creation, ensuring the data is accurate.  The Director, Medical Reviewer will report to the GMSA Executive Medical Director, Medical Operations.

Essential Job Functions and Responsibilities:

• These may include but are not limited to:

  • Serve as Medical Reviewer in MMRT and CRC, ensuring all medical materials are medically accurate, balanced, scientifically accurate, non-misleading, relevant, and unbiased, in collaboration with Legal and Regulatory
  • Optimize MMRT processes (e.g., references are correctly annotated, strength of evidence in reference is appropriate, rationale for comments/requested changes are sufficiently backed)
  • Collaborate with GMSA, regulatory, legal and commercial teams and utilize Veeva Medcom/PromoMats to review medical/non-promotional and promotional materials in a timely manner
  • Work with Medical strategy team and piece owners to contribute to medical content creation, ensuring messaging is accurate.
  • Collaborate with project owners to resolve comments and ensure compliance
  • Attend all scheduled MMRT and CRC meetings as required
  • Provide clear guidance to project owners to ensure efficient and appropriate submission of materials through the review process including through weekly office hours as needed
  • Work with the MMRT and CRC coordinators to optimize review planning and establish the agenda
  • Provide feedback to improve Veeva Medcom review workflows for different material types
  • Stay updated on FDA regulations and industry trends relevant to medical and promotional materials development
  • Proficiency in technologies for reviewing medical and promotional materials (e.g., Veeva PromoMats and/or MedComms)
  • Excellent written and oral communication skills
  • Demonstrated ability to analyze, concisely, timely, and accurately summarize, and present complex scientific and medical data to a diverse audience of both scientific and non-scientific professionals
  • A commitment to producing high-level results and performing duties with integrity
  • Ability to work independently and within a group setting
  • Excellent organizational skills
  • Must be competent in problem solving and sound decision-making
  • Strong attention to detail and demonstrable ability to identify and correct errors
  • Aptitude for conflict resolution and de-escalation
  • Performs other duties and responsibilities as assigned

• Advanced/doctoral degree (PharmD, PhD) with 7- 8 years of experience in a health/biological science required, plus a minimum of 2-3 years of experience in a supervisory/leadership role
• Minimum 5-6 years of experience as a medical communication/ medical reviewer in appropriate functions (e.g., Medical Affairs, Medical Information, or Scientific Communications)
• Prior experience reviewing medical materials including Field Medical slide decks, Medical Information response documents and frequently asked questions, medical booth congress materials, congress presentations, scientific communications platforms, clinical pathway submissions, and AMCP dossiers
• Prior experience reviewing promotional materials including print and digital advertisements (websites, core visual aids, leave behinds, rep triggered emails, etc.), speaker programs, congress exhibits, sales trainings, and internal communications/field direction memos

At Karyopharm, base pay is one part of a competitive total rewards package that includes comprehensive benefits (medical, dental, vision, 401(k), and more), equity and the potential to receive annual target bonuses. Actual pay is based on factors such as location, experience, skills, education, and internal equity. We maintain broad salary ranges to reflect market conditions and the specialized nature of our work. The anticipated base salary range for this position is $170 - $240 K USD.

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), team members 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)
• Cell phone allowance