MRC Operations Lead

Job not on LinkedIn

🕒 October 1

🏖️ New Jersey – Remote

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💵 $90k - $95k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

🦅 H1B Visa Sponsor

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👻 Ghost score 11%

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Logo of Trilogy

Trilogy

201 - 500 employees

Founded 1989

🚘 Automotive

🛡️ Insurance

📦 Logistics

Automotive • Insurance • Logistics

Trilogy is a comprehensive business platform that helps software companies become more efficient and profitable by streamlining business functions such as development, product management, and R&D. Founded by Stanford dropouts in Silicon Valley in 1989, Trilogy relocated to Austin, Texas in the early 90s and significantly contributed to the city’s transformation into a tech hub. Trilogy focuses on providing high-quality software and unmatched business efficiency managed by the top 1% of global tech talent. The platform offers end-to-end solutions including engineering, customer support, technical product management, finance & accounting, innovation R&D, SaaS operations, renewals, inside sales, and recruiting. By leveraging insights and continuous improvements, Trilogy enables exponential business growth and seamless operations for software companies around the world.

📋 Description

• Manage end-to-end medical Material Review Committee operations, including agenda management, meeting facilitation, workflow routing, and quality control • Triage materials and progress workflows across Veeva Vault PromoMats and MedComms • Oversee submission intake, review readiness, and material quality control • Manage volume projections and capacity planning • Own adherence to SOPs and governance standards for medical material review • Track compliance, identify gaps, and facilitate remediation • Serve as the primary escalation point for operational risks, bottlenecks, send-back decisions, and workflow issues • Enforce metadata standards, referencing requirements, and submission-readiness criteria • Liaise with Brand/Medical teams, Medical Directors, Project Owners, Agencies, and Reviewers • Integrate into weekly functional meetings across medical affairs and evidence-generation teams • Facilitate concept consultation and pre-clearance forums • Drive adherence to timelines, forecasting schedules, and MLR processes • Provide daily direction and support to coordinators, agencies, and internal partners • Oversee escalation and send-back decisions, Rule-of-5 application, level-ups, and expedited requests • Lead tracker calls, planning and prioritization meetings, and content-alignment touchpoints • Own operational KPIs, dashboards, and performance reporting • Establish agency scorecards, recurring-issue tracking, and accountability measures • Support Quarterly Business Reviews • Improve forecasting processes and tooling and strengthen capacity modeling and operational visibility • Support training content, process documentation, reference materials, and onboarding guidelines • Support evolution of the review model and broader operational optimization and transformation initiatives

🎯 Requirements

• 5–7+ years of relevant operations experience in the biotech/pharmaceutical industry • Experience in MRC/PRC operations and MLR coordination • Experience in medical material review and understanding of materials requiring promotional review • Strong understanding of commercial and medical marketing functions within the biotech/pharmaceutical industry • Deep hands-on technical knowledge of Veeva Vault PromoMats and MedComms • Excellent analytical, decision-making, and problem-solving skills • Ability to navigate complex regulatory environments and ensure compliance • Exceptional communication, interpersonal, emotional intelligence, and conflict-resolution abilities • Ability to influence without authority • Proven people-leadership and team-oversight capability • Proactive, self-starter comfortable with ambiguity • Working fluency with AI and GenAI-enabled tools • Digital literacy with productivity, analytics, and dashboarding tools such as Excel and Power BI • Ability to interpret and act on data • Adaptability toward emerging AI-enabled review and content technologies • Ability to partner with technology teams to pilot, validate, and operationalize AI-enabled efficiencies while maintaining compliance and quality standards

🏖️ Benefits

• Global growth opportunities • Mentorship and leadership development • Fast-track career opportunities • Inclusive and diverse workplace culture

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