Medical Operations Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee comprehensive mMRC operations, which includes managing agendas, facilitating meetings, routing workflows, and ensuring quality control across Veeva Vault PromoMats and MedComms.

• Assess materials and advance workflows while supervising submission intake, review readiness, and material quality assurance.

• Manage volume forecasting and capacity planning.

• Collaborate with stakeholders to address fluctuations in material volume and forecasting requirements.

• Ensure compliance with SOPs and governance standards for the review of medical materials.

• Monitor compliance, identify deficiencies, and support remediation efforts.

• Act as the main escalation point for operational risks, bottlenecks, send-back decisions, and workflow challenges.

• Enforce standards for metadata, referencing requirements, and criteria for submission readiness.

• Serve as the primary operational liaison among Brand/Medical teams, Medical Directors, Project Owners, Agencies, and Reviewers.

• Participate in weekly functional meetings within the medical affairs and evidence-generation sectors.

• Facilitate concept consultations and pre-clearance forums.

• Drive adherence to timelines, forecasting schedules, and MLR processes among Project Owners and Agencies.

• Provide daily guidance and support to coordinators, agencies, and internal partners.

• Oversee coordination activities, escalation and send-back decisions, level-ups, and expedited requests.

• Lead tracker calls, planning and prioritization meetings, and content alignment sessions.

• Own operational KPIs, dashboards, and performance reporting.

• Establish and maintain agency scorecards, track recurring issues, and implement accountability measures.

• Assist with Quarterly Business Reviews.

• Enhance forecasting processes and tools while improving capacity modeling and operational visibility.

• Support the development of training materials, process documentation, reference resources, and onboarding guidelines.

• Promote continuous improvement and aid in the evolution of review models as well as broader operational transformation initiatives.

⛳️ Requirements

• 5–7+ years of pertinent operations experience in the biotech/pharmaceutical sector, particularly in MRC/PRC operations and MLR coordination.

• Preferred experience in medical material review and workflows.

• Understanding of which materials require promotional review.

• Strong grasp of commercial and medical marketing functions within the biotech/pharmaceutical industry.

• In-depth, hands-on technical expertise in Veeva Vault PromoMats and MedComms from both an administrative and content-creation viewpoint.

• Excellent analytical, decision-making, and problem-solving abilities.

• Capability to navigate complex regulatory landscapes and ensure compliance.

• Outstanding communication and interpersonal skills.

• High emotional intelligence and conflict-resolution capabilities.

• Ability to influence without formal authority.

• Proven leadership and team oversight skills.

• Enthusiasm for process improvement and operational structure.

• Proactive and self-motivated attitude; comfortable working in uncertain environments.

• Ability to gather diverse stakeholder input to inform decisions and foster innovative solutions.

• Working proficiency with AI and GenAI-enabled tools for reporting, summarization, forecasting, and workflow optimization.

• Digital proficiency with modern productivity, analytics, and dashboarding tools like Excel and Power BI.

• Capacity to analyze and act on data effectively.

• Curiosity and flexibility regarding emerging AI-enabled review and content technologies.

• Ability to collaborate with technology teams to pilot, validate, and implement AI-driven efficiencies while maintaining compliance and quality standards.

🏝️ Benefits

• Opportunities for global growth.

• Accelerated career advancement opportunities.

• Mentorship programs to assist employees in developing their skills as people and account managers.

• Entrepreneurial career experiences.

• A culture that values inclusion and diversity.