Responsibilities

• Manages CCC submission processes for assigned brand(s), including reviewing submissions for completeness and accuracy, circulating materials for review, and answering any questions related to the process
• Schedules and facilitates CCC team meetings, ensuring that materials are prioritized appropriately and comments are captured clearly and accurately
• Monitors and manages materials in the approval queue to ensure they are moving efficiently through the system
• Coordinates final approvals with Regulatory department and assists with audits or other legal issues as needed
• Maintains content records including re-assigning tasks, running reports, and updating document properties
• Drives adherence with SOPs to improve CCC coordination and streamline processes
• Guides stakeholders through the CCC lifecycle, providing continuous education to internal and external partners on processes and the document review system, Veeva Vault
• Works with manager to run metrics and present to cross-functional teams
• Assists with creation of and/or updates to process documentation and training materials
• Supports management, maintenance, and improvements to Veeva Vault functionality and training documentation

Requirements

• Bachelor’s degree required
• 4+ years of professional experience required
• Marketing operations or creative agency experience
• Experience in a regulated industry (Pharmaceuticals, Finance, Medical Device, etc.)
• Veeva Vault experience
• Excellent project management skills including proactivity, planning, prioritization, meeting management, and the ability to meet deadlines
• Strong attention to detail and focus on data accuracy
• Problem solving skills, including the ability to interpret information, draw conclusions, and make recommendations
• Excellent written and verbal communication skills
• Proficient with Microsoft Office applications including Excel, PowerPoint, and Word

Benefits

• Alkermes offers a competitive benefits package.