Project Coordinator

Indegene Inc.; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Indegene is seeking a seasoned MLR/PRC coordinator to drive end-to-end workflows, ensure first-time-right submissions, and support regulatory compliance in a fast-paced biopharma environment.

You will chair meetings, manage reviewer routing, and collaborate with Medical, Legal, Regulatory, and Marketing teams to deliver accurate promotional material on time.

Qualifications

• 5+ years in MLR/PRC coordination within the biopharma industry.
• Hands-on experience with electronic review systems like Veeva Vault PromoMats.
• Understanding of FDA regulations for pharmaceutical advertising.
• Cross-functional stakeholder management across Medical, Legal, Regulatory, Marketing.
• Moderate to advanced Microsoft Office skills.

Responsibilities

• Manage MLR/PRC workflows end-to-end—from concept review through final approval, including resubmissions and re-reviews.
• Assign and route reviewers based on content type and regulatory requirements.
• Proactively manage the material pipeline, including active workflows and offline activities.
• Chair PRC/MLR meetings—lead discussions, capture decisions, and log actions.
• Prepare and distribute meeting agendas; update based on reviewer feedback and workflow status.
• Attend brand, therapy area, and business-unit prioritization meetings.

Skills

Interpersonal skills

Project management

Presentation skills

Meeting facilitation

Stakeholder management

Tools

Power BI

SmartSheet

Veeva Vault PromoMats

Job description

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
Looking to jump-start your career?

We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene's high-speed growth.

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.

Must Have

You will be responsible for:

A. Workflow Management

• Manage MLR/PRC workflows end-to-end-from concept review through final approval, including resubmissions and re-reviews
• Assign and route reviewers based on content type and regulatory requirements
• Proactively manage the material pipeline, including active workflows and offline activities

B. Quality Control (First-Time-Right)

• Perform readiness assessments at each stage using pre-submission checklists to ensure SOP compliance before review initiation
• Flag non-compliant or incomplete submissions; partner with originators to resolve-escalate where necessary
• Manage material expiry tracking and timely re-review/retirement

C. MLR/PRC Meeting Facilitation

• Chair PRC/MLR meetings-lead discussions, capture decisions, and log action items in the review system
• Prepare and distribute meeting agendas; update based on reviewer feedback, and workflow status
• Attend brand, therapy area, and business-unit-specific prioritization meetings

D. Stakeholder & Agency Management

• Serve as the primary coordination interface between reviewers, project owners, agencies, and material owners
• Drive agency accountability for submission quality and process adherence
• Share job aids and policy guidance; identify training gaps and elevate

E. Reporting & Analytics

• Generate compliance reports on submission, review, approval, expiry, and usage status
• Extract and analyze process metrics; provide actionable recommendations
• Maintain therapeutic area trackers and planning & prioritization forecasts
• Run periodic reports (90-day re-review, Open Jobs Status) to monitor job progression

F. Process Improvement

• Proactively identify optimization opportunities aligned with business objectives
• Co-create actionable strategies with stakeholders to enhance efficiency and measurable impact
• Support process documentation, training materials, and refresher sessions

Your impact:

About you:

• Excellent interpersonal and collaboration skills
• Project management skills and experience preferred
• General understanding of FDA regulations for pharmaceutical advertising and promotion
• Strong presentation and meeting facilitation skills
• 5+ years in MLR/PRC coordination within the biopharma industry
• Hands-on expertise in electronic review systems (e.g., Veeva Vault PromoMats)-submission routing, metadata management, approval tracking
• Cross-functional stakeholder management across Medical, Legal, Regulatory, Marketing, and Agency partners
• Experience in QC frameworks, submission compliance validation, and promotional material lifecycle governance
• Proficiency in reporting and dashboarding (system-native reports, Power BI, SmartSheet)

Must have:

• Experience working in a pharmaceutical or healthcare advertising environment
• Moderate to Advanced Microsoft Skills (Outlook, Excel, Word, PPT)

Nice to have:

• General understanding of FDA/other regulations for pharmaceutical advertising and promotion

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, colour, 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, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.