The posting
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a MRC (Medical) Operations Lead based in United States.
The MRC (Medical) Operations Lead oversees the day-to-day operations and logistical execution of medical material review processes. You will coordinate workflows, facilitate review forums, and ensure materials move efficiently through the appropriate approval stages. The role combines operational leadership, compliance oversight, stakeholder coordination, and continuous process improvement. You will work closely with Medical, Brand, Legal, Regulatory, agency, and project teams to maintain high standards of quality and accountability. Using data, technology, and emerging AI-enabled tools, you will improve forecasting, reporting, capacity planning, and workflow efficiency. This is a highly collaborative role with significant influence across a complex healthcare environment, offering the opportunity to strengthen operational infrastructure and support broader commercialization objectives.
Accountabilities:
- Manage the end-to-end execution of medical material review operations, including agenda management, meeting facilitation, workflow routing, submission intake, and quality control across Veeva Vault PromoMats and MedComms.
- Triage materials and monitor workflow progression, ensuring submissions meet review-readiness, metadata, referencing, and quality requirements before advancing to reviewers.
- Manage volume projections and capacity planning while partnering with stakeholders to address fluctuations in material demand and forecasting requirements.
- Own adherence to SOPs and governance standards, track compliance gaps, coordinate remediation, and ensure review activities align with applicable requirements.
- Serve as the primary escalation point for operational risks, bottlenecks, workflow issues, send-backs, and expedited requests, escalating appropriately when required.
- Act as the key operational liaison between Brand and Medical teams, Medical Directors, Project Owners, agencies, and reviewers.
- Facilitate concept consultation and pre-clearance forums, translating strategic direction from Medical Directors into actionable content and process guidance without setting medical strategy.
- Ensure Project Owners and agencies adhere to agreed timelines, forecasting schedules, submission requirements, and MLR processes.
- Provide daily direction and support to coordinators, agencies, and internal partners while overseeing escalation, send-back, and prioritization decisions.
- Lead operational forums including tracker calls, planning and prioritization meetings, and content alignment sessions.
- Own operational KPIs, dashboards, and reporting covering cycle times, forecasting accuracy, quality trends, resource utilization, and overall performance.
- Develop agency scorecards, track recurring issues, establish accountability measures, and support Quarterly Business Reviews.
- Improve forecasting processes, capacity modeling, and operational tooling while reducing reliance on manual processes and strengthening visibility.
- Support training, onboarding, process documentation, and reference materials while fostering a culture of continuous improvement.
- Contribute to the evolution of review models and broader operational transformation initiatives, including the adoption of AI-enabled technologies and digital content workflows.
- 5–7+ years of relevant operations experience within the biotech or pharmaceutical industry, particularly in MRC/PRC operations and Medical, Legal, and Regulatory coordination.
- Experience with medical material review processes and a strong understanding of which materials require promotional review.
- Solid understanding of commercial and medical marketing functions within the pharmaceutical or biotech sector.
- Deep, hands-on knowledge of Veeva Vault PromoMats and MedComms, including experience from both administrative and content-creation perspectives.
- Strong analytical, decision-making, and problem-solving abilities, with the judgment required to operate within complex regulatory and compliance environments.
- Exceptional communication and interpersonal skills, including emotional intelligence, conflict resolution, stakeholder management, and the ability to influence without formal authority.
- Demonstrated people-leadership and team-oversight capabilities, combined with a strong focus on process improvement and operational excellence.
- Proactive and self-directed approach, with the ability to work effectively through ambiguity, gather input from diverse stakeholders, and drive practical decisions and solutions.
- Working fluency with AI and GenAI-enabled tools, with the ability to apply them to reporting, summarization, forecasting, workflow optimization, and other operational activities.
- Strong digital literacy across productivity, analytics, and dashboarding tools such as Excel, Power BI, or equivalent platforms.
- Curiosity and adaptability toward emerging AI-enabled review and content technologies, with an interest in supporting AI-assisted MLR workflows and digital content initiatives.
- Ability to collaborate effectively with technology teams to pilot, validate, and implement AI-enabled efficiencies while maintaining compliance, quality, and operational standards.
- Compensation of $90,000–$95,000 USD
- Remote position in the United States
- East Coast location preferred
- Equal opportunity employment environment
- Inclusive workplace committed to diversity and non-discrimination
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
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