Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.
We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.
The Associate Director, US Medical Review will serve as a Medical Affairs member of the US Materials Review Committee (MRC).
This position will report to the Head of USMA Integrated Medical Capabilities and be part of the Medical Review and Insights Community.
The Associate Director, US Medical Review, will be responsible for the Medical Review of Promotional Materials to ensure the communication of accurate, consistent, and timely information regarding products and therapeutic areas. This includes leading the MRC medical review sub-team in providing solutions-oriented feedback and working collaboratively and efficiently with other cross-functional team members, such as Medical Affairs, Marketing, Legal, and Regulatory. Additionally, this role will serve as the lead for co-creation in material development with Marketing. The Associate Director, US Medical Review, will maintain ongoing communication across the Medical Review team and Medical Affairs Therapeutic Area functional leads to support informed decision making.
ROLES & RESPONSIBILITIES
- Serve as Lead for a sub-team of Medical Reviewer(s) in US Materials Review Committee (MRC)
- Ensure statements are scientifically valid and accurate, truthful and not misleading, and that promotional claims are adequately supported, including the appropriateness of references cited
- Identifies and communicates complex materials and associated benefit-risk decisions to Medical Review Community Lead
- Communicates and collaborates effectively with cross-functional groups to cultivate a positive relationship
- Represent Medical Review function in Medical Affairs Matrix meetings for informed decision making
- Identifies sub-team process efficiencies related to Medical Review
- Maintain scientific knowledge including labeling, associated therapeutic areas, publication plans, treatment guidelines and competitor landscape, through ongoing internal and external data sources (e.g., training, conferences)
SKILLS AND COMPETENCIES
- Ability to critically evaluate literature, interpret complex data, write effectively, articulate information to a variety of audiences, and effectively negotiate with counterparts from cross-functional areas
- Detail-oriented and ability to manage various projects, solve problems, deliver on commitments, work with multidisciplinary teams, and appropriately elevates complex topics to Medical Review Community Lead
- Must be a strong team player/ demonstrates flexibility and a positive attitude
- Working knowledge of FDA regulations related to role
REQUIREMENTS
- Doctorate Degree (PharmD/MD/PhD)
- Minimum of 5 years of experience in the pharmaceutical or biotechnology setting predominately within Medical Affairs or related roles
- Direct promotional/medical review experience required (3 years)
- Prior experience in Neurology or Rare Disease preferred
- Strong scientific/medical written and verbal communication skills required
At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.