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Alkermes

Marketing Operations Specialist – MLR

Posted 7 Days Ago
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Hybrid
Waltham, MA, USA
80K-90K Annually
Mid level
Hybrid
Waltham, MA, USA
80K-90K Annually
Mid level
Manages the pharmaceutical Medical/Legal/Regulatory review process for assigned brands, coordinating submissions, stakeholders, committee meetings, approval queues, final regulatory approvals, records, reports, and audits. Ensures SOP adherence, educates internal and external partners on Veeva Vault processes, supports system improvements and training documentation, tracks metrics, and provides project management support.
The summary above was generated by AI

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.

Responsibilities

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

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

 

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

HQ

Alkermes Waltham, Massachusetts, USA Office

852 Winter Street, Waltham, MA 02451, US, Waltham, MA, United States, 02451

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