Manager, MRC Operations

argenx•Boston, MA
•Remote

About The Position

The Manager, MRC Operations is responsible for the daily operational oversight and logistical execution of Material Review Committee (MRC) operations, contributing to argenx’s performance, competitiveness, and operational excellence. The role has a critical compliance responsibility for ensuring adherence to applicable laws and regulations governing the Medical, Legal, Regulatory (MLR) review process. The manager optimizes MRC Operations by continuously evaluating and evolving processes and technologies to improve efficiency and quality. This position is fully remote, with a preference to hire on the East Coast.

Requirements

  • 2–4+ years of relevant operations experience in the biotech or pharmaceutical industry.
  • 2+ years of relevant experience coordinating the MLR review process.
  • Strong understanding of the commercial marketing function within the biotech or pharmaceutical industry.
  • Excellent analytical, decision-making, and problem-solving skills.
  • Exceptional communication and interpersonal abilities, including the ability to engage and influence stakeholders at all levels.
  • Ability to navigate complex regulatory environments and ensure compliance across marketing operations tactics.
  • Proactive self-starter able 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 that support a first-class operations infrastructure.

Responsibilities

  • Manage MRC operations, including agenda management, meeting facilitation, VEEVA PromoMats and MedComms use and 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 promote understanding and alignment on operational processes and material-review technology platforms.
  • 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 the material-review SOP, track compliance, and facilitate remediation as necessary.
  • Collaborate with internal teams to promote innovation, share best practices, and identify opportunities for operational improvement and efficiency.

Benefits

  • Eligible to participate in short-term and long-term incentive programs, subject to plan terms and applicable policies.
  • Comprehensive benefits package, including retirement savings plans, health benefits, and other benefits subject to applicable plan and program guidelines.
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