Promotional Review & Veeva Submissions Lead

INDEGENE LIMITED•New Jersey, NJ

4h•$100,000 - $130,000

About The Position

The Promotional Review & Veeva Submissions Lead serves as the operational point of contact for PRC/MLR processes and owns assigned promotional submissions from readiness through completion of the review cycle. The role prepares and routes materials through Veeva Vault PromoMats, coordinates review timelines and stakeholders, tracks comments and decisions, manages rework and resubmissions, and ensures final dispositions are documented in Veeva. The position checks submission readiness and quality, including completeness and accuracy of metadata, attachments, references, supporting documentation, and file versions. It participates in PRC/MLR meetings, records feedback and action items, resolves or escalates process risks and ambiguous requirements, and maintains submission documentation and performance metrics. The role also monitors workload and capacity, identifies operational trends and bottlenecks, and supports continuous process improvement. The role requires at least nine years of relevant experience and direct, hands-on responsibility for PRC/MLR submissions, along with strong Veeva Vault PromoMats expertise and knowledge of pharmaceutical promotional compliance. Graduate, postgraduate, or doctoral education in life sciences is stated, with pharmaceutical sciences, medicine, or dentistry preferred. Compensation is listed as a $100,000–$130,000 base salary range across U.S. pay areas. The role is eligible for medical, dental, vision, life and disability insurance, a 401(k), sick leave, vacation paid time off, and paid holidays.

Requirements

At least 9 years of experience in pharmaceutical promotional review, MLR/PRC operations, promotional material submissions, or regulatory communications, with hands-on responsibility for PRC/MLR submissions.
Demonstrated ability to manage submissions end-to-end, including readiness assessment, preparation and routing, tier selection according to guidelines, review monitoring, comment and rework management, resubmission, and review-cycle completion.
Strong hands-on experience with Veeva Vault PromoMats, including submission routing, metadata, document and version control, annotations, anchoring, workflow management, and review/resubmission cycles.
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 and gray areas and appropriately clarify or escalate them.
Ability to identify incomplete or incorrect submission inputs, documentation gaps, version or metadata issues, and other submission risks before review.
Excellent verbal and written communication skills and ability to work across Brand, agencies/AORs, Medical, Legal, Regulatory, and operational teams.
Ability to clarify ambiguous or conflicting feedback, drive required actions, challenge incomplete handoffs, and escalate issues appropriately.
Ability to independently manage multiple concurrent submissions, review cycles, deadlines, dependencies, and changing priorities while maintaining quality and timely execution.
Prior involvement in the creation, execution, or review of pharmaceutical promotional or marketing assets, with understanding of creative and compliance considerations.
Execution-oriented and accountable, organized and detail-oriented, proactive, able to solve problems, diplomatic and appropriately assertive, adaptable, and committed to continuous improvement and learning.
Graduate, post-graduation, or doctorate in life sciences; listed qualifications also include BPharm, MPharm, PharmD, MS, or BAMS.

Nice To Haves

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 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.
Educational background in pharmaceutical sciences, medicine, or dentistry.
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.

Responsibilities

Serve as the primary point of contact for PRC/MLR process questions and help stakeholders understand requirements, decisions, expectations, and compliance considerations.
Plan and align submission timelines with internal and external stakeholders; identify, communicate, resolve, and escalate process issues, dependencies, and risks.
Own assigned PRC/MLR submissions from readiness through review-cycle completion, preparing and routing materials through Veeva in accordance with applicable requirements.
Determine submission tiers using established guidelines and escalate when the appropriate tier is unclear.
Monitor submission status, follow up on pending or stalled actions, communicate risks and delays, track comments and decisions, coordinate responses, and manage resubmissions through documented final disposition.
Review submission materials and supporting files for complete and accurate information, including metadata, attachments, references, supporting documentation, file versions, and other required components.
Validate submission requirements against applicable PRC/MLR processes, brand requirements, and internal guidelines; document and follow up on missing, incomplete, inconsistent, or incorrect inputs and confirm resolution or escalate.
Participate in PRC/MLR review meetings, capture reviewer feedback and decisions, document actions, owners, and timelines, and track meeting actions through resolution or escalation.
Coordinate comment resolution across review rounds, translate feedback into actionable instructions, seek clarification on unclear or conflicting comments, assign required changes, and verify comments are addressed before resubmission.
Support creation and maintenance of SOPs, checklists, playbooks, templates, and guidance; document lessons learned and recurring process issues, monitor adherence, and support agreed improvements.
Monitor submission volume, priorities, timelines, and capacity; identify constraints and bottlenecks, coordinate sequencing and timelines, escalate capacity issues, and take on spillover work as required within agreed priorities.
Perform quality checks and spot-checks on submissions before review or resubmission, identify errors and risks, escalate high-risk or ambiguous issues, and confirm required corrections are implemented.
Track agreed submission performance metrics, analyze delays, errors, bottlenecks, and improvement opportunities, provide insights to stakeholders and leadership, and lead or support process reviews and follow-up actions.