Job Description

AD / Director, Global Medical Reviewer

The AD / Director, Global Medical Reviewer is responsible for the development and implementation of regulatory strategies for specific projects, while serving as the regulatory lead on the respective program teams. He/she will also be the regulatory contact with relevant regulatory authorities, as appropriate.

As a Karyopharmer, reporting to Executive Director, Regulatory Affairs, you will positively impact patients' lives by:

1. 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
2. Optimize MMRT processes (e.g., references are correctly annotated, strength of evidence in reference is appropriate, rationale for comments/requested changes are sufficiently backed)
3. 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
4. Work with Medical strategy team and piece owners to contribute to medical content creation, ensuring messaging is accurate.
5. Collaborate with project owners to resolve comments and ensure compliance
6. Attend all scheduled MMRT and CRC meetings as required
7. 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
8. Work with the MMRT and CRC coordinators to optimize review planning and establish the agenda
9. Provide feedback to improve Veeva Medcom review workflows for different material types
10. Stay updated on FDA regulations and industry trends relevant to medical and promotional materials development
11. Proficiency in technologies for reviewing medical and promotional materials (e.g., Veeva PromoMats and/or MedComms)
12. Excellent written and oral communication skills
13. 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
14. A commitment to producing high-level results and performing duties with integrity
15. Ability to work independently and within a group setting
16. Excellent organizational skills
17. Must be competent in problem solving and sound decision-making
18. Strong attention to detail and demonstrable ability to identify and correct errors
19. Aptitude for conflict resolution and de-escalation
20. Performs other duties and responsibilities as assigned

Candidate Profile & Requirements:

• 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

Our Value Proposition:

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

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