Key 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
Provides project management support as needed for department or cross-functional team
Reporting to the Senior Manager of Marketing Operations for promotional review, the Specialist will be responsible for managing the Medical/Legal/Regulatory (MLR) review process. This person will be the primary point of contact for all stakeholders, including project owners, agency representatives, and reviewers. Responsibilities include planning, prioritization, and meeting facilitation for the copy review process, which is called CCC at Alkermes, and ensuring compliance and process adherence of all committee stakeholders.
Alkermes has adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home.
| Location | Waltham, MA |
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