Position: MRC (Medical) Operations Lead
Location: US (remote; East Coast preferred)
Role Overview:
The MRC (Medical) Operations Lead is an all-encompassing role responsible for the daily operational oversight and logistical execution of the medical Material Review Committee (mMRC). The role both triages materials and progresses workflow and serves as the primary point of contact for all stakeholders participating in medical material creation, review, and approval. It ensures the timely, compliant, and high-quality review of medical and scientific materials, and carries a critical compliance responsibility for adherence to applicable laws, regulations, and SOPs governing the Medical, Legal, and Regulatory (MLR) review process. The Lead will continuously optimize the effectiveness of mMRC operations by evolving processes, governance, and enabling technologies to drive speed, accountability, and operational excellence, while supporting the client's broader commercialization and growth objectives.
Key Accountabilities & Responsibilities
Operational Execution:
- Manage the end-to-end execution of mMRC operations, including agenda management, meeting facilitation, workflow routing, and quality control across Veeva Vault PromoMats and MedComms.
- Triage materials and progress workflow, overseeing submission intake, review readiness, and material QC to ensure only review-ready materials advance, protecting reviewer time and cycle-time targets.
- Manage volume projections and capacity planning; partner with stakeholders to address material volume fluctuations and forecasting needs.
- Governance & Compliance:
- Own adherence to SOPs and governance standards for medical material review; track compliance, identify gaps, and facilitate remediation as necessary.
- Serve as the primary escalation point for operational risks, bottlenecks, send-back decisions, and workflow issues, operating to a defined escalation matrix and escalating to Director as appropriate.
- Enforce metadata standards, referencing requirements, and submission readiness criteria to drive first-time-right quality and approval efficiency.
- Stakeholder & Medical-Strategy Facilitation:
- Act as the primary point of contact and operational liaison between Brand/Medical teams, Medical Directors, Project Owners, Agencies, and Reviewers.
- Integrate into weekly functional meetings across the medical affairs and evidence-generation community (excluding leadership forums such as IST and USLT).
- Facilitate concept consultation and pre-clearance forums, operationalizing Medical Directors' strategic direction into actionable content and process guidance (facilitating, not setting, medical strategy).
- Drive Project Owner and Agency adherence to timelines, forecasting schedules, and processes as determined by MLR stakeholders; escalate non-compliance.
- Team Oversight & Escalation:
- Provide daily direction and support to coordinators, agencies, and internal partners on mMRC execution and process adherence.
- Oversee coordination activities, align on escalation and send-back decisions (including Rule-of-5 application), and manage level-ups and expedited requests to ensure appropriate escalation and alignment.
- Lead operational forums - tracker calls, planning and prioritization meetings, and content alignment touchpoints.
- Reporting, Metrics & Continuous Improvement
- Own operational KPIs, dashboards, and performance reporting - cycle times, forecasting accuracy, quality trends, and resource utilization.
- Establish and maintain agency scorecards, recurring-issue tracking, and accountability measures; support Quarterly Business Reviews (QBRs).
- Improve forecasting processes and tooling, reducing reliance on manual methods and strengthening capacity modelling and operational visibility.
- Support the development and maintenance of training content, process documentation, reference materials, and onboarding guidelines; drive a continuous-improvement culture.
- Support the evolution of the review model (e.g., indication-based to franchise- or asset-based structures) and contribute to broader operational optimization and transformation initiatives.
Desired Skills & Experience
- 5-7+ years of relevant operations experience in the biotech/pharmaceutical industry, particularly in MRC/PRC operations and MLR coordination.
- Preference for experience in medical material review and workflows, in addition to an understanding of, and experience with, what types of materials should undergo promotional review.
- Strong understanding of the commercial and medical marketing functions within the biotech/pharmaceutical industry.
- Deep, hands-on technical knowledge of Veeva Vault PromoMats and MedComms, from an administrative and content-creator perspective.
- Excellent analytical, decision-making, and problem-solving skills, with the ability to navigate complex regulatory environments and ensure compliance.
- Exceptional communication and interpersonal abilities, with strong emotional intelligence, conflict resolution, and the ability to influence without authority.
- Proven people-leadership and team-oversight capability, with a passion for process improvement and first-class operational infrastructure.
- Proactive, self-starter comfortable with ambiguity, able to seek diverse stakeholder input to drive decisions and innovative solutions.
AI Fluency & Digital Literacy
- Working fluency with AI and GenAI-enabled tools, with a demonstrated ability to apply them to operational tasks such as reporting, summarization, forecasting, and workflow efficiency.
- Digital literacy across modern productivity, analytics, and dashboarding tools (e.g., Excel, Power BI, or equivalent), with comfort interpreting and acting on data.
- Curiosity and adaptability toward emerging AI-enabled review and content technologies, with an interest in supporting AI-assisted MLR workflows and Digital Content Factory initiatives as they mature.
- Ability to partner with technology teams to pilot, validate, and operationalize AI-enabled efficiencies while maintaining compliance and quality standards.
COMPENSATION: $90,000-$95,000USD
