Marketing Operations Specialist – MLR
Alkermes
Summary
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.
Job description
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
Qualifications
Education and Experience:
- Bachelor’s degree required
- 4+ years of professional experience required
Preferred Skills Knowledge Qualifications:
- 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
- Ability to work with individuals in different functional areas and at different levels in the organization
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
- Ability to work with individuals in different functional areas and at different levels in the organization
Benefits
- Performance pay bonus
- Competitive benefits package
Company overview
Alkermes plc is a global biopharmaceutical company specializing in neuroscience-focused medicines for psychiatric and neurological disorders. Founded in 1987 and headquartered in Dublin, Ireland, the company maintains a significant research and development center in Waltham, Massachusetts, and a manufacturing facility in Wilmington, Ohio. Alkermes has established itself as a leader in developing treatments for complex conditions including schizophrenia, bipolar I disorder, alcohol dependence, and opioid dependence. The company's portfolio includes proprietary commercial products such as Lybalvi (olanzapine/samidorphan), Aristada (aripiprazole lauroxil), and Vivitrol (naltrexone), alongside a robust pipeline of clinical and preclinical candidates targeting neurological disorders like narcolepsy and idiopathic hypersomnia. With approximately 1,800-2,100 employees worldwide, Alkermes combines deep neuroscience expertise with sophisticated development capabilities to address traditionally overlooked or stigmatized conditions, maintaining a patient-centered approach to drug development and commercialization.