TheManager, MRCOperations isresponsible forthe daily operational oversight andthe logistical execution of Material Review Committee (MRC)operationsthat contributesto argenx’sperformance, competitiveness, and operational excellence. This rolehas a critical compliance responsibility for ensuring adherence to applicable laws and regulationsaround the Medical, Legal, Regulatory(MLR)review process.Themanagerwill optimizethe effectiveness of MRC Operationsby continuously evaluating/ evolvingprocesses 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 solutionsto support first class operations infrastructure

#LI-Remote