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Promotional Review & Veeva Submissions Lead
Key Responsibilities & Deliverables
Serve as PRC/MLR point of contact: Serve as the primary point of contact for questions related to the PRC/MLR process across relevant stakeholder groups. Help stakeholders understand PRC/MLR requirements, decisions, process expectations, and trade-offs between creative ideas and compliance requirements. Plan and align submission timelines based on project requirements in coordination with internal and external stakeholders. Proactively identify, communicate, and help resolve process-related issues, dependencies, and risks. Flag and escalate issues that cannot be resolved within the role’s delegated authority to the appropriate stakeholder and follow through until a decision or resolution is obtained.
PRC submission: Own the operational execution of assigned PRC/MLR submissions from submission readiness through review-cycle completion. Prepare and submit materials for PRC/MLR review and route submissions through Veeva in accordance with applicable PRC/MLR processes and requirements. Determine and plan the appropriate submission tier based on established guidelines, escalating for clarification where the appropriate tier is unclear. Coordinate with the business owner and relevant stakeholders to move materials into review. Monitor the status of assigned submissions, proactively follow up on pending actions or stalled reviews, and communicate material risks or delays to relevant stakeholders. Track PRC/MLR comments and decisions, coordinate required responses and updates, and manage resubmissions as required until the review cycle is completed and the final disposition is documented in Veeva.
Check projects and intake for submission readiness: Review materials and supporting files handed over for submission to confirm that all information required to execute the submission is available, accurate, and complete, including metadata, attachments, references/supporting documentation, correct file versions, and other required submission components. Validate the material and submission requirements against applicable PRC/MLR processes, brand requirements, and internal guidelines before assigning or moving work to offshore teams. Identify and document missing, incomplete, inconsistent, or incorrect inputs received from the AOR, Brand, or other stakeholders. Communicate gaps to the responsible stakeholder, follow up on outstanding items, and confirm that identified gaps are resolved before submission, unless an authorized stakeholder has explicitly approved proceeding otherwise. Escalate unresolved readiness issues that could impact submission timelines or quality.
Participate in PRC/MLR meetings & capture feedback: Participate in relevant PRC/MLR review meetings, virtually or in person, to capture reviewer feedback, provide process or submission context where appropriate, and support clarification of comments during the meeting. Document reviewer comments, decisions, required actions, owners, and relevant timelines. Route actions and feedback to the appropriate stakeholders promptly after the meeting and ensure that feedback requiring action is incorporated into the comment-resolution workflow. Track outstanding actions arising from the meeting through resolution or escalation.
Drive comment resolution and rework: Own the coordination and tracking of comment resolution for assigned submissions across review rounds. Track content/copy and other applicable feedback from PRC/MLR reviewers, Brand, agencies, and relevant stakeholders. Translate reviewer and stakeholder feedback into clear, detailed, and actionable markups or instructions for the appropriate cross-functional or offshore teams. Where feedback is unclear, conflicting, incomplete, or not actionable, proactively obtain clarification from the appropriate reviewer or stakeholder rather than making assumptions. Coordinate resolution of conflicting comments and escalate when a decision falls outside delegated authority. Ensure required changes are assigned to the appropriate owner, completed, and returned for review within agreed timelines. Verify that comments have been addressed before resubmission and maintain visibility of open, resolved, and escalated comments through completion of the review cycle.
Maintain and improve process documentation: Support the creation and ongoing maintenance of SOPs, checklists, playbooks, templates, and guidance materials related to the PRC/MLR submission process. Document lessons learned, recurring issues, process gaps, and effective practices to support continuous improvement. Monitor adherence to established procedures within the scope of the role, identify recurring or systemic deviations, and escalate them to the appropriate process owner or leadership. Support implementation and communication of agreed process improvements.
Monitor workload and capacity: Maintain visibility of current and upcoming submission volume, priorities, timelines, and capacity requirements across assigned work. Identify potential workload constraints, competing priorities, bottlenecks, or timing risks early and communicate them to the appropriate stakeholders. Plan and adjust submission sequencing and timelines, in coordination with relevant stakeholders, to support on-time delivery. Proactively escalate capacity constraints that cannot be resolved within available resources. Take on spillover submissions or other submission-related work, as required and within agreed priorities, to support timely completion of critical projects.
Quality checks and risk management: Perform quality checks on assigned submissions before they enter or re-enter PRC/MLR review to identify submission errors, missing requirements, inconsistencies, or process misalignments. Conduct additional spot-checks on selected submissions as required. Identify potentially high-risk items, ambiguous requirements, or gray areas and escalate them to the appropriate PRC/MLR reviewer, process owner, or stakeholder with relevant context and supporting rationale rather than independently making decisions outside delegated authority. Confirm that required corrections resulting from identified quality issues are implemented before submission or resubmission. Document recurring errors and ensure relevant learnings are incorporated into checklists, guidance, or process improvements to reduce recurrence.
Measure performance & drive improvements: Track and maintain agreed PRC/MLR submission performance metrics, including, as applicable, percentage of submissions completed on time, turnaround time, number of feedback/review rounds, rework or error trends, and stakeholder satisfaction. Analyze submission performance to identify recurring delays, errors, bottlenecks, and improvement opportunities. Provide relevant stakeholders and leadership with timely insights on submission performance, risks, and trends. Lead or support process reviews following major campaigns, recurring issues, or significant error events; identify root causes and improvement actions; and track agreed actions through implementation.
Desired Profile:
Relevant experience: At least 9 years of experience in pharmaceutical promotional review, MLR/PRC operations, promotional material submissions, or regulatory communications environments, with demonstrated hands-on responsibility for PRC/MLR submissions.
PRC/MLR submission expertise: Demonstrated experience managing assigned submissions end-to-end, including assessing submission readiness, preparing and routing materials, applying appropriate submission tiers based on established guidelines, monitoring review status, managing comments and rework, resubmitting materials, and driving the review cycle through completion. This role requires direct execution of submission activities.
Veeva Vault PromoMats expertise: Strong hands-on experience with Veeva Vault PromoMats, including submission routing, metadata, document and version control, annotations, anchoring, workflow management, and review/resubmission cycles.
Regulatory and promotional knowledge: Strong understanding of pharmaceutical promotional compliance, including FDA/OPDP expectations, labeling alignment, claims and supporting references, and promotional risk considerations. Ability to identify potential compliance concerns or gray areas and appropriately clarify or escalate them.
Quality and attention to detail: Demonstrated ability to identify incomplete or incorrect submission inputs, documentation gaps, version or metadata issues, and other potential submission risks before materials enter review.
Stakeholder management and communication: Excellent verbal and written communication skills, with demonstrated ability to work across Brand, agencies/AORs, Medical, Legal, Regulatory, and operational teams. Able to clarify ambiguous or conflicting feedback, drive required actions, challenge incomplete handoffs, and escalate issues appropriately.
Workload and priority management: Demonstrated ability to independently manage multiple concurrent submissions, review cycles, deadlines, dependencies, and changing priorities while maintaining quality and timely execution.
Creative exposure: Prior involvement in the creation, execution, or review of pharmaceutical promotional/marketing assets, with an understanding of creative and compliance considerations.
Preferred Qualifications
Experience serving on an MLR/PRC committee as a reviewer or working closely with Medical, Legal, and Regulatory reviewers.
Experience providing substantive feedback on promotional claims, copy, references, messaging, labeling alignment, or creative execution.
Experience working in executing submission-related work.
Experience developing or maintaining PRC/MLR SOPs, checklists, playbooks, templates, and guidance materials.
Experience identifying operational bottlenecks, recurring submission issues, or process gaps and implementing improvements.
Experience tracking and analyzing submission performance metrics, turnaround times, review rounds, quality trends, or other operational KPIs.
Skills & Personal Attributes
Execution-oriented and accountable: Comfortable personally executing submission work when required and taking ownership of assigned submissions through completion rather than operating solely as a coordinator.
Highly organized and detail-oriented: Able to manage multiple submissions, versions, comments, dependencies, and timelines with a high degree of accuracy.
Proactive and anticipatory: Identifies submission gaps, risks, dependencies, and potential delays early and drives appropriate action before they affect timelines or quality.
Strong problem solver: Able to navigate incomplete or ambiguous information, seek appropriate clarification, determine next steps within established guidelines, and escalate decisions outside delegated authority.
Diplomatic and appropriately assertive: Able to push for actions, challenge incomplete or unclear inputs, resolve issues across stakeholders, and escalate when needed while maintaining productive working relationships.
Adaptable and flexible: Comfortable managing shifting priorities, urgent submissions, and fluctuating workloads in a fast-paced environment.
Continuous improvement mindset: Identifies recurring issues and opportunities to improve submission quality, efficiency, processes, and ways of working.
Continuous learner: Stays current with evolving regulatory expectations, PRC/MLR practices, industry trends, and relevant process and technology developments.
Education
Graduate, post-graduation, or doctorate in life sciences
Educational background in Pharmaceutical sciences, medicine or dentistry is preferred
Optional and good to have: Regulatory Affairs Certification |Certificate in Advertising / Promotional Labeling or Regulatory Marketing / Compliance | Completion of certificate programs, coursework or short courses in regulatory affairs, regulatory science, medical product advertising law, or digital marketing compliance
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 qualification.
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.
Bpharm/ Mpharm/ PharmD/ MS /BAMS
Compensation & Benefits Transparency Statement
Base Salary Range: $100k-$130k
The compensation range displayed reflects the full span of pay across all of our U.S. geographic pay areas and experience levels. Your actual base salary offer will be determined based on multiple factors, including:
Geographic Pay Area (US 1 through US 5, reflecting cost‑of‑labor differences)
Experience & Qualifications relevant to the role
Internal Equity alignment with employees in similar roles and levels
What This Means for You
The minimum of the posted range represents the starting point for candidates in the lowest cost‑of‑labor pay areas (US 5).
The maximum of the posted range represents the upper threshold for candidates in the highest cost‑of‑labor pay areas (US 1 / US 2).
Candidates are aligned to pay areas based on their primary work location.
For Current Employees
Posted salary ranges reflect the full compensation band across all U.S. pay areas and experience levels. Your individual compensation is based on your specific pay area, hire date, performance trajectory, and internal equity. Differences between your current salary and the posted range are not indicative of a pay discrepancy. Please contact HR with any questions.
Benefits Overview
This role is eligible for a comprehensive benefits package, including medical, dental, and vision coverage; life and disability insurance; a 401(k)-retirement plan; seven (7) sick leave days, vacation paid time off, and paid holidays; all in accordance with Company plans. Specific benefits are governed by applicable plan documents.
Indegene is committed to pay equity and transparency. We regularly benchmark our compensation against market data to ensure competitive and fair pay practices across all locations.
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.
We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.