Indegene is a global consultancy at the forefront of driving innovation in the Pharmaceutical industry, through combining medical and commercial expertise with innovative digital and AI technologies. We enable global healthcare organizations address complex challenges and drive better health and business outcomes by seamlessly integrating analytics, technology, operations and medical expertise. Find out more at indegene.com.
Indegene is on a mission to empower every healthcare enterprise in its transformation journey. We are uniquely positioned to solve the challenges of the healthcare industry through our combination of deep medical knowledge and verticalized technology and help make healthcare affordable and accessible to every person on the planet.
Summary Overview
The Marketing Operations Associate works cross-functionally to project manage the review process for advertising and promotional materials for approved drug and/or device products. The Associate is responsible for ensuring the efficiency of the MLR Committee process, involving Medical, Legal, Regulatory, and Compliance teams, and for conformance with company policies and procedures.
Key Responsibilities
- Lead and manage cross-functional promotional review (MLR) committee meetings. Build and manage meeting agendas as a partner to Marketing and facilitate meetings while memorializing MLR Reviewer comments and job requirements. The associate should be comfortable dealing with participants of varying levels and experience, and be able to steer productive meeting discussions. The associate is also responsible to manage all meeting logistics, including scheduling.
- Manage all aspects of the review process for multiple brands. The associate works independently on designated brands managing all aspects of both offline and live reviews. The associate works closely with Brand Marketing, the MLR Committee, Compliance, and the rest of Marketing Operations, to proactively identify and resolve issues and ensure reviews are efficiently completed throughout various stages of the process. Associate will utilize system and reporting to effectively communicate and actively manage jobs with Brand/Project Originators.
- Enable best practices and SOP conformance. Use experience and judgment to identify jobs that may not be consistent with best practices, company policies, or FDA guidance. Associate also ensures that all SOP requirements are met. Provides guidance and training as required to all MLR participants.
- Interface with Editorial, Production, and Regulatory to assist with system execution of submission processes. The associate is knowledgeable in each area to help with timely submissions and execution to ensure potential issues are resolved for overall achievement of deadlines (Proofing requirements, Regulatory Affairs return of jobs, 2253 submission to OPDP, etc.).
- Collaborate with Marketing Operations, IT and Brand to provide feedback and support for process and system enhancements. Associate will actively contribute to ongoing development in these areas as subject matter expert via weekly meetings and system testing for issue resolution and/or enhancements before pushing updates to the production environment. Associate will take the lead or co-lead projects and/or assignments, as required, to ensure department goals are achieved.
Must Have
- Fluent in German and English
- Experience working in a pharmaceutical or healthcare advertising environment
- Familiarity with promotional review systems such as Veeva or Zinc strongly preferred
- Moderate to Advanced Microsoft Skills (Outlook, Excel, Word, PPT)
- Experience with editing helpful
- 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
- Bachelor’s Degree preferred
- Minimum of 1-year marketing operations experience
Indegene are innovators at heart and real innovation for us means constantly obsessing over what will drive success for our customers in the future. No wonder 18 of the top 20 global biopharma organizations lean on us for an agile and enduring partnership. With more than 3000 brilliant employees spread across the US, Europe, China, and India, we have delivered over 100 strategic engagements and fully commercialized over a $2 billion portfolio.
- We have brought together a group of incredibly passionate and brilliant people and entrusted them to solve some of healthcare’s most challenging problems, which has led to our culture being centered on passion, innovation, and collaboration. We’re passionate about healthcare; we believe that technology and innovation will carve an indomitable path in transforming healthcare for the better, and to achieve this, we collaborate with the best minds in the medical and technological domains
