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Us Advertising/promotion Regulatory Reviewer
3 months ago
Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.Purpose:
The purpose of the US Advertising/Promotion Regulatory Reviewer-LCCI role is to deliver accurate, balanced, and substantiated product and disease communications for assigned assets.
Primary Responsibilities:
This job description is intended to provide a general overview of the job requirements at the time it was prepared.
The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.
Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Regulatory Expertise
_ Review promotional tactics__ and _
_internal field-based communications_
Serve as Regulatory representative for US brand teams for promotional tactics and internal field-based communications
- Provide high quality, timely and decisive regulatory advice that enables business partners to make wellinformed decisions
- Ability to interpret product claim instructions and ensure appropriate implementation in final promotional tactics
- Communicate regulator expectations by utilizing OPDP feedback received by Lilly, interpretation of applicable laws, regulations and guidance's, and knowledge of FDA enforcement actions.
- Contribute to business risk mitigation strategies related to advertising, promotion
- Provide regulatory advice consistent with Customer Information Quality (CIQ) system requirements and processes
- Build, maintain, and leverage relationships with Lilly team members to effectively influence the implementation of appropriate communications.
_ Process Excellence_
- Provide timely and quality review of 2253 promotional material submissions to FDA for assigned marketed products
- Provide timely and quality review of FDA advisory comment submission materials
- Support direct to distribution workflow (E.g., sample cartons, monthly social media submissions)
- Prepare and/or review VVPM submission binders for 2253 and advisory comment submissions
- Manage expedited submission requests related to promotional materials, coordinating with RDE as needed
- Manage FDA correspondence templates including periodic reviews and revisions as needed
- Draft FDA correspondence letters, as requested
- Support electronic archival in RIM for FDA incoming correspondence and Records of Contact
- Monitor external Federal Register notifications related to OPDP research; facilitate internal discussions and commenting on proposed research, as needed
- Manage advertising/promotion SharePoint site to facilitate shared learning (e.g., training resources, SWAT assessments, etc)
- Support data on file activities related to publishing syntax
_ Deviation Management and Change Control_
- Provide timely completion of impact assessments for deviation management and input into change controls for assigned marketed product, consulting with Indybased team as needed
_ Collaborate with other Regulatory colleagues_
- Partner with US Regulatory Scientist and Labeling Operations to manage labeling revisions to balance consideration of business implication and regulatory compliance
- Partner with USbased Ad/Promo Regulatory Reviewers to develop and implement product discontinuation plans, including determination if safety claims are impacted and determining timing for updates
- Communicate and share key information to enable seamless execution of US regulatory strategy and promotional activity
- Partner with USbased team to support special projects related to advertising/promotion
Lead/Influence/Partner
- Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, Deliver in internal and external interactions
- Models the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
- Constructively challenge teams to reach the best solutions to issues
- Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions
Minimum Qualification Requirements:
- Master's Degree in a scientific or health sciences discipli
