Manager, MRC Operations

About the role

The Manager, MRC Operations plays a crucial role in overseeing and executing Material Review Committee (MRC) operations. This role ensures compliance with applicable laws and regulations surrounding the Medical, Legal, Regulatory (MLR) review process. The manager is responsible for optimizing operational effectiveness through continuous process evaluation and technology adaptation.

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.

Requirements

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, 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.

Qualifications

Desired Skills And Experience

Skills

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.

Benefits

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.

Pay

The annual base salary hiring range for this position is $100,000.00 - $137,500.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors.

Schedule

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