What are the responsibilities and job description for the Manager, US Medical Promotional Review position at argenx US Inc?
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 Manager, US Medical Promotional Review, will be responsible for the Medical Review of Promotional and/or 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 Promotional Review, and other cross-functional team members, such as: Marketing, Legal, and Regulatory. Additionally, this role will support the Reference Library, and related operational processes related role. The Manager, US Medical Promotional Review, will maintain ongoing communication across the Medical Review Community and MRC Review Committee.
ROLES & RESPONSIBILITIES
Serve as the Medical Reviewer for scientific accuracy in the promotional US Materials Review Committee (MRC) and/or the US Medical Materials Committee (MMRC); support Global Medical Review as needed
Provide medical review to ensure statements are scientifically valid and accurate, truthful and not misleading, and that promotional claims are adequately supported, including the appropriateness of references cited
Anticipates risk and proactively elevates to AD, US Medical Promotional Review
Maintain ongoing communication and collaboration within the Medical Review Community and MRC Review Committee
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 effectively network and 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)
1 year of experience in the pharmaceutical industry or 2-3 years retail/hospital/clinical experience preferred
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.
