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.
ResponsibilitiesKey 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
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
The annual base salary for this position ranges from $80k to $90k. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
#LI-TT1 #LI-hybrid
Skills Required
- Bachelor's degree
- 4+ years of professional experience
- Marketing operations or creative agency experience
- Experience in a regulated industry, such as pharmaceuticals, finance, or medical devices
- Veeva Vault experience
- Project management skills, including planning, prioritization, meeting management, and deadline management
- Strong attention to detail and data accuracy
- Problem-solving skills, including interpreting information, drawing conclusions, and making recommendations
- Excellent written and verbal communication skills
- Proficiency with Microsoft Office applications, including Excel, PowerPoint, and Word
- Ability to work with individuals across different functional areas and organizational levels
What We Do
Alkermes focuses on the development of innovative medicines that seek to address unmet needs of people living with serious mental illness, addiction, and cancer. As a fully-integrated, global biopharmaceutical company, we apply our scientific expertise and proprietary technologies to develop products that are designed to make a meaningful difference in the way patients manage their disease. We are inspired by some of the most pressing public health challenges of our time to help advance innovation with the potential to improve treatment options and outcomes for patients. Beyond our important mission of developing medicines, we believe it is our responsibility to take a holistic approach as we seek to support patients, caregivers, and broader impacted communities. In this context we also work to help support and enhance the systems through which these complex diseases are treated. We are committed to patient engagement, disease education and awareness, and advocacy for important policies that support equitable access to quality treatment. Headquartered in Dublin, Ireland, we have an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. See our Community Guidelines: https://www.alkermes.com/social-community-guidelines








