Manager, MRC Operations

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

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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.