Job Description
Reporting to the 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 recently 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 FDA 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
• 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

#LI-TT1 #LI-hybrid
About Us
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.