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Associate Director, US Medical Review

Associate Director, US Medical Review

argenxNew Haven, CT, US
16 hours ago
Job type
  • Full-time
Job description

Associate Director, Us Medical Review

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 be responsible for overseeing the medical review of promotional materials and leading a dedicated indication sub-team within the us medical review community. This position plays a critical role in ensuring scientific accuracy and cross-functional collaboration across medical affairs, marketing, legal, and regulatory teams. The role also serves as the medical review lead for co-creation during material development with marketing and contributes to informed, evidence-based decision-making across the therapeutic area.

Roles & Responsibilities

  • Lead an indication sub-team of medical reviewers within the us medical review community, ensuring promotional materials are scientifically accurate, truthful, and compliant with regulatory standards.
  • Provide solutions-oriented feedback and collaborate effectively with cross-functional stakeholders.
  • Represent the medical review function in medical affairs matrix meetings to support strategic decision-making.
  • Identify and implement process efficiencies within the medical review sub-team.
  • Maintain up-to-date scientific knowledge, including product labeling, therapeutic areas, treatment guidelines, publication plans, and competitive landscape.

Skills And Competencies

  • Strong ability to critically evaluate scientific literature and interpret complex data.
  • Excellent written and verbal communication skills tailored to diverse audiences.
  • Proven ability to manage multiple projects, solve problems, and meet deadlines.
  • Effective collaborator in a matrixed environment with a proactive and flexible mindset.
  • Working knowledge of FDA regulations relevant to promotional and medical review.
  • Requirements

  • Doctorate degree (PharmD, MD, or PhD).
  • 5+ years of experience in pharmaceutical or biotechnology industry, primarily within medical affairs.
  • At least 3 years of direct experience in promotional / medical review.
  • Prior experience in neurology or rare disease preferred.
  • Strong scientific and medical 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.

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