Project Coordinator (MLR/PRC promotional review coordinator) - US Based (remote)
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Trilogy Writing and Consulting
Princeton, NJ, US
Summary
Manage end-to-end MLR/PRC promotional review workflows, including routing, quality control, and meeting facilitation. Serve as the primary interface between stakeholders and agencies while generating compliance reports and driving process improvements.
Job Description
We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations 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 and variety 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 with the reliability you seek. We hire the best and trust them from day 1 to deliver global impact, handle teams and be responsible for the outcomes while our leaders support and mentor you.
We are a profitable 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 of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to
PROJECT COORDINATOR (MLR/PRC Promotional Review Coordinator)
You will be responsible for:
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
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
MLR/PRC Meeting Facilitation:
- Chair PRC/MLR meetings—lead discussions, capture decisions, and log action items in the review systemPrepare and distribute meeting agendas; update based on reviewer feedback, and workflow status
- Attend brand, therapy area, and business-unit-specific prioritization meetings
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 escalate
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
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
Must Have:
- Bachelor's degree
- 5+ years in MLR/PRC (promotional review coordination, workflow management, and reporting support) within the biopharma industry; experience working in a pharma or healthcare advertising environment
- Excellent interpersonal and collaboration skills
- Project management skills and experience preferred
- Strong presentation and meeting facilitation skills
- Experience with 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
- Proficiency in reporting and dashboarding (system-native reports, PowerBI, SmartSheet)
- Attention to detail, high-volume multitasking, analytical mindset
- Remote in US but availability to work Eastern Time Zone hours
Compensation: $75,000USD
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 qualification.
At Trilogy, medical writing is our passion. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. Our writers are integral parts of our clients’ teams: proactively planning, coordinating and writing their clinical documents to meet timelines, with a readability that reduces the time for review and approval. We have been helping pharmaceutical companies and clinical research organizations of all sizes, worldwide, to streamline their documentation processes for over 18 years – either as support on a one-off document or the entire clinical development program.
We provide our clients with a constructive advice on their projects: we guide our clients’ teams through the writing process and ask them the right questions in order to produce documents that communicate effectively. Our writers are trained to understand that our job is not to produce a data dump: it is to think about the data available and work with the team to pull out the messages and present them as clearly as possible, so that a reviewer can quickly find the information they are looking for and easily understand the story to be told. Our approach to writing clinical documentation ideally results in a minimum of clarifying questions from reviewers, speeding the process of review and ultimately leading to faster approval.
Trilogy currently has more than 80 writers, who are located in 3 offices: Frankfurt in Germany (HQ), London in the UK, and Durham, North Carolina in the US.
Founded
2002
Company size
51-200 employees
Industry
Writing and Editing
Org type
Privately Held
Headquarters
Frankfurt
At Trilogy, medical writing is our passion. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. Our writers are integral parts of our clients’ teams: proactively planning, coordinating and writing their clinical documents to meet timelines, with a readability that reduces the time for review and approval. We have been helping pharmaceutical companies and clinical research organizations of all sizes, worldwide, to streamline their documentation processes for over 18 years – either as support on a one-off document or the entire clinical development program.
We provide our clients with a constructive advice on their projects: we guide our clients’ teams through the writing process and ask them the right questions in order to produce documents that communicate effectively. Our writers are trained to understand that our job is not to produce a data dump: it is to think about the data available and work with the team to pull out the messages and present them as clearly as possible, so that a reviewer can quickly find the information they are looking for and easily understand the story to be told. Our approach to writing clinical documentation ideally results in a minimum of clarifying questions from reviewers, speeding the process of review and ultimately leading to faster approval.
Trilogy currently has more than 80 writers, who are located in 3 offices: Frankfurt in Germany (HQ), London in the UK, and Durham, North Carolina in the US.
Founded
2002
Company size
51-200 employees
Industry
Writing and Editing
Org type
Privately Held
Headquarters
Frankfurt