Responsibilities

• Partner with key internal and external stakeholders across the TG (MS) commercialization team to ensure a collaborative, compliant, and efficient MLR review process
• Lead the facilitation and organization of our weekly cross functional MLR meetings, ensuring stakeholder and business needs are being addressed according to project timelines
• Support each stakeholder team with annual MLR forecasting for content approvals across training, marketing, market access and medical affairs
• Proactively partner with team during offline content reviews to monitor and document progress
• Manage documentation, clarity and reconciliation of content review and approval comments
• Plan and manage weekly MLR meeting agendas across the teams to meet content approval needs and deadlines
• Monitor timelines to ensure pre-meeting documents have been distributed or routed to the MLR review team according to process timeline requirements to support an efficient use of scheduled meeting / review time
• Facilitate, in partnership with appropriate stakeholders, the delivery of approved materials for Veeva CRM upload, print production, Compliance Wire, etc.
• Continuously ensure content approvals are following the appropriate review /approval paths and document retention guidelines
• Prepare and manage 2253 submissions to the FDA, working closely with regulatory and submission vendor

Requirements

• Associates Degree with 5+ years of relevant MLR career experience within the pharmaceutical industry
• Strong facilitation and communication skills in managing MLR stakeholder collaboration
• Expert listening skills and ability to probe for undisclosed information
• Capable of engaging with senior management and external agency partners
• Demonstrated experience in successfully supporting brand launches through the MLR process
• Working knowledge of FDA regulations, pharmaceutical advertising submission guidelines and timelines to facilitate promotional and educational content approvals
• Highly organized with exceptional attention to detail
• Experience in working with various MLR technical and organizational tools
• Experience proofreading technical documents
• Ability to build, manage, and lead multiple cross-functional partnerships and initiatives simultaneously