Sr. Manager, US Medical Review MMRC at argenx in Boston, Massachusetts

Job Description:

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 Sr. Manager, US Medical Review MMRC will serve as a Medical Affairs member of the US Medical Materials Committee (MMRC).

This position will report to the Head of USMA Integrated Medical Capabilities and be part of the Medical Review Community.

The Sr. Manager, US Medical Review MMRC will be responsible for the Medical Review of Medical Affairs Materials to ensure the communication of accurate, consistent, and timely information regarding products and therapeutic areas. This includes providing solutions-oriented feedback and working collaboratively within the Medical Review Community, including the AD, US Medical Review, and other cross-functional team members, such as: Medical, Legal, and Regulatory. The Sr. Manager, US Medical Review, will maintain ongoing communication across the Medical Review Community.

ROLES & RESPONSIBILITIES

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  Serve as the Medical Reviewer for scientific accuracy in the US Medical Materials Committee (MMRC)

  
  
  
  

  • Provide independent medical review to ensure statements are scientifically valid and accurate, truthful and not misleading, including the appropriateness of references cited

  
  

  • Identifies and communicates challenges to AD, US Medical Review

  
  
  
  

• Effective ongoing communication and collaboration within the Medical Review Community, including Medical Affairs Project Owners




• Communicate and collaborate effectively with cross-functional teams to cultivate a positive relationship




• Maintain scientific knowledge, including labeling, associated therapeutic areas, relevant literature, treatment guidelines and competitor information, through ongoing internal and external data sources (e.g., training, conferences)




• Fully comply with all argenx policies and applicable laws, regulations, and ethical standards, and make decisions within guidelines and policies

SKILLS AND COMPETENCIES

• Able to partner with internal stakeholders and embrace cross-functional working




• Strong operational capabilities, eye for detail, and commitment to advance and adhere to processes




• Ability to critically evaluate literature, interpret complex data, write effectively, articulate information to a variety of audiences, and negotiate with counterparts from cross-functional areas




• Must be a strong team player with a positive attitude and demonstrate flexibility to plan and prioritize in a dynamic environment




• Ensures the highest degree of quality and medical accuracy for all outputs developed




• Completes all work in accordance with regulatory requirements, industry standards, and argenx policies

REQUIREMENTS

• Doctorate Degree (PharmD/MD/PhD)




• 2-4 years biopharmaceutical industry in medical affairs leading the review of marketing and/or scientific communications




• Experience in content management systems (Veeva Vault or similar) is 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.

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