Manager, MRC Operations

argenx US Inc; United States; Remote; USD 100,000 - 140,000; Full time

Benefits offered by this job

Incentive programs

Comprehensive benefits package

Job summary

argenx is seeking a Manager, MRC Operations to oversee the daily operational execution of Material Review Committee processes, ensuring compliance with MLR regulations and SOPs. This fully remote role prefers East Coast candidates and requires coordinating with vendor and internal partners.

You will manage agenda, training content, documentation, volume projections, and process improvements within a fast-growing biotech environment, contributing to high-quality compliant material reviews and

Qualifications

• 2-4+ years of relevant operations experience in biotech/pharmaceuticals.
• 2+ years coordinating MLR review process or similar regulatory reviews.
• Strong understanding of the commercial marketing function within biotech/pharma.
• Excellent analytical, decision-making, and problem-solving abilities.

Responsibilities

• Manage execution of MRC operations including agenda management, meeting facilitation, VEEVA PromoMats and MedComms use & documentation, and quality control processes.
• Support 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

Skills

Operations

MRC Coordination

MLR Knowledge

Biotech Industry

Stakeholder Management

Job description

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.

If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at [e-mail].

argenx honors the terms of our written agreements with the recruiting and staffing agencies that we retain and contract with to assist us with talent searches and other recruiting needs. Accordingly, all resumes and referrals that recruiting and staffing agencies proactively share with argenx that (i) were not solicited or requested by argenx's internal Talent Acquisition team and (ii) were sent in the absence of a valid, written agreement between argenx and the firm, recruiter, or agency, may be pursued by argenx and are ineligible for payment of referral or other fees.

Our formal recruitment process includes interviews with members of argenx's talent acquisition team and other interviewers that occur in person at our offices, or via Zoom or Teams video calls. Interview processes that involve a formal offer from argenx will include written employment documentation on official argenx letterhead.

argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility.