Title:  Promotional Review Manager

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

This role will serve as the single point of contact for all brand internal and external stakeholders. The individuals in these roles are operational subject matter experts with skillsets ranging across content review and approval processes, agile methodologies, and agency engagement who will collaborate with brands on timeline planning, launch and label updates, volume and demand forecasting, escalating GCMA continuous improvements and delivering action-oriented metrics and reports. 
•    Brand level BAU operational support for content review and approval processes or any instance that requires agency planning or direction
•    BAU Training & onboarding support for internal and external stakeholders (post-launch)
•    Circulates best practices, guidance, and policy changes consistently across MLR teams they support
•    Launch timeline planning and project management
•    Label updates and critical milestone project prioritization
•    Escalates opportunities for process improvements to Functional Lead 
•    Conducts regular audits on RC meetings & escalates key findings 
•    Oversees RC scheduler 
•    GCMA assistance & issue resolution
•    Maintains brand stakeholder lists across Marketing, Reviewers, and Agencies
•    Acts as a voice of the customer to the Quality Assurance Specialists

Timeline Management & Brand Planning
•    Consults with marketing and agencies on all launch & label update content planning and timeline management (day 0 launch planning)
•    Leads content demand planning and forecasting for assigned brands and escalates to the CSM Functional Lead 
•    Provides counsel to job owners on planning for the review & approval process, including timing considerations and providing them with information on where relevant policies and guidance documents are available 
•    Attends brand status and planning meetings with marketing & agency partners (if required)

Promotional Material Process Oversight & Management
•    Responsible for brand team operational effectiveness and identifies process optimization opportunities
•    Partners with RC Captain to identify and course correct any RC process improvements or answer any and all process related questions 
•    Works closely with the Commercial team, MLR/RC Committee members, and CE team o proactively identify and resolve issues and ensure reviews are efficiently completed throughout various stages of the process
•    Creates and circulates best practices and policy or process changes consistently across brand teams
•    Interacts with all relevant internal and external stakeholders, including Agency Partners, Marketing Material Owner, and the Regulatory Submissions team to ensure adherence to all Final Sample FDA submission timelines and policies
•    Partners with marketing material owners and other stakeholders in the re-review process
•    Leads operational process and timelines for all tactics related to label updates for assigned brands
•    Monitors Content Review and Approval Operational Effectiveness and RC Norms Management and escalates findings to the CE Team for assigned brands
•    Maintains assigned brand and agency contact lists and emails

Good to have

RC Scheduling & Prioritization
•    Manages agenda distribution and alignment with RC norms to commercial, RC members, and Agency Partners 
•    Audits RC meetings to ensure meetings are efficient and conducted according to guidance and escalates findings to the CE Team 
•    Identifies agencies or Material Owners frequently missing agreed upon submission timelines, recommends remediation plan, and escalates to the CE Team 
•    Live RC Agenda Management, including ensuring that adequate time is allotted for scheduled items, RC Scheduler tasks and system training, adherence to RC Norms, capturing reviewer planned absences, and providing input on impact to deliverables and providing feedback on types of materials based on Tier that require RC Live Meeting time 

Training & Onboarding Support
•    Provides process, policy, and electronic review system training and onboarding as well as assistance to external and internal users
•    Day-to-day POC for GCMA assistance & issue resolution 

Reporting, Metrics, and Audits
•    Runs 15-, 30-, and 60-day re-review reports on a monthly basis to provide Material Owners advanced notice of pieces approaching expiration
•    Informs quarterly metrics reports and insights, with direct remedies to optimize process or RC team performance in partnership with the CE Team 
•    Supports any corporate or annual audit processes related to content
•    Escalates and documents any content deviations as part of quality plan
•    Runs reports to identify all materials/assets that require changes as a result of a label update
•    Runs weekly reports to inform weekly prioritization and agenda planning for both offline and online reviews

Additional Support & Process Improvements
•    Completes UAT for any US or Canada requested enhancements in partnership with the Review and Approval CE Team 
•    Escalates on-the-ground observations and brand feedback to the CE Team 
•    Proactively identifies any process or system improvements and escalates to the CE Team 
•    Collaborates with assigned brand teams to facilitate efficient and compliant submissions and adherence to standards, guidance, and policy 
•    BAU support and maintenance of any new policies or process enhancements

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.