Manager, MRC Operations

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. 

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, Japan, and Switzerland.

The Manager, MRC Operations is responsible for the daily operational oversight and the logistical execution of Material Review Committee (MRC) operations that contributes to argenx’s performance, competitiveness, and operational excellence. This role has a critical compliance responsibility for ensuring adherence to applicable laws and regulations around the Medical, Legal, Regulatory (MLR) review process. The manager will optimize the effectiveness of MRC Operations by continuously evaluating / evolving processes and technologies to ensure efficiency and quality.

This position is fully remote and preference is to hire on the East Coast. 

Key Accountabilities/Responsibilities:

• Manage the execution of MRC operations including agenda management, meeting facilitation, VEEVA PromoMats and MedComms use & documentation, and quality control processes.
• Support the development and maintenance of training content, process documentation, and reference materials for commercial and medical material review.  
• Support training sessions for the MRC community to ensure understanding and alignment on operational processes and technology platforms for material review 
• Provide daily support and direction to vendor and internal partners on MRC execution and adherence to established processes
• Manage volume projections and collaborate with stakeholders to address material volume fluctuations and capacity needs
• Ensure compliant adherence to SOP for material review, tracking compliance, and facilitating remediation as necessary
• Collaborate with internal teams to promote innovation, share best practices, and identify areas for operational improvement and efficiency
  

Desired Skills and Experience:

• 2-4+ years of relevant operations experience in the biotech/pharmaceutical industry
• 2+ years relevant experience coordinating MLR review process
• Strong understanding of the commercial marketing function within the biotech/pharmaceutical industry.
• Excellent analytical, decision-making, and problem-solving skills.
• Exceptional communication and interpersonal abilities, with the skill to engage and influence stakeholders at all levels.
• Ability to navigate complex regulatory environments and ensure compliance across all marketing operations tactics .
• Proactive, self-starter with the ability to take initiative and work independently while being comfortable with ambiguity.
• Ability to seek diverse input from multiple stakeholders to drive decisions and innovative solutions to support first class operations infrastructure

‎

This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.

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.

Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at [email protected].

If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at [email protected]. Only inquiries related to an accommodation request will receive a response.