Sr Systems Analyst, IT Clinical Regulatory Medical

Alkermes Plc

Waltham, MA

JOB DETAILS
SKILLS
Analysis Skills, Best Practices, Business Processes, Clinical Practices/Protocols, Computer Systems, Cross-Functional, Data Analysis, Data Collection, Data Migration, Data Sets, Disease, Drug Development, Establish Priorities, FDA (Food and Drug Administration), Health Information Technology, Information Technology & Information Systems, Internet Security, Maintain Compliance, Medical Organizations, Medical Products, Needs Assessment, Neurology, Neuroscience, Pre-Clinical Development, Problem Solving Skills, Psychiatry and Mental Health, Quality Assurance, Regulations, Regulatory Compliance, Regulatory Requirements, Release Management/Engineering, Research & Development (R&D), Standard Operating Procedures (SOP), Strategic Planning, Supplier Relationship Management (SRM), System Validation, Systems Analysis, Technical Support, Vendor/Supplier Relations
LOCATION
Waltham, MA
POSTED
30+ days ago

ESSENTIAL AREAS OF RESPONSIBILITY:

  • Work with stakeholders to understand their business processes, requirements and data flows using various elicitation techniques

  • Create and update all software lifecycle documentation

  • Partner with cross functional teams including R&D, Infrastructure, Validation, QA, vendors

  • Develop and manage vendor relationships, coordinating configurations, upgrades, releases, request management and support activities

  • Lead data migration and curation projects as needed throughout the R&D organization

  • Analyze gaps, recommend opportunities for improvement that fit the business needs

  • Coordinate issue resolution with internal and external technical support providers

  • Prioritize tasks between strategic initiatives, ongoing system releases and day to day activities

  • Ensures adherence to regulatory requirements, cybersecurity standards, department policies, procedures and SOPs

  • Build and foster effective relationships between the business stakeholders and IT

  • Oversee vendor relationships for implemented systems and solutions

  • Ensure adherence to FDA computer systems validation compliance

POSITION SUMMARY:

Alkermes is seeking a Sr. Systems Analyst, within the R&D IT team. This person would work closely with our Development, Clinical, Regulatory and Medical, DSPV organizations to evaluate, implement, enhance and support current systems and solutions. They will assist in optimizing data capture, data aggregation, and data analysis. The preferred candidate will utilize their experience to implement key functionality within these groups to help facilitate the development/clinical/regulatory/medical teams. Their role will include but not be limited to working with the various scientific areas to identify key data sets, facilitating the implementation of required infrastructure/solution where necessary, and working closely with the scientists and other users to understand their business needs.

All work of the Sr. Systems Analyst is conducted within regulatory guidelines and industry best practices.

Why join Team Alkermes?

Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee 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 characteristic protected by local, 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.

About the Company

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Alkermes Plc