We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com
What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it?
We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career while providing the reliability you seek. We believe in creating leaders of tomorrow and mentor our team to help them grow and nurture them as people managers and account managers.
We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries: healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. This combination will lead to a truly differentiated experience for you.
If this excites you, then apply below.
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
EQUAL OPPORTUNITY
Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualifications.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
