Sr Systems Analyst II, R&D Systems

Alkermes; Boston (MA); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

Hybrid work model

Office in Waltham MA

Annual performance bonus

Competitive benefits

Job summary

Alkermes is seeking a Sr. Systems Analyst within the R&D IT team to evaluate, implement, enhance and support systems across Development, Clinical, Regulatory and Medical groups.

This role focuses on optimizing data capture, aggregation and analysis to support discovery, clinical and regulatory activities. They will collaborate with scientists and IT to translate business needs into robust infrastructure and solutions, while ensuring compliance with FDA and GxP guidelines.

Qualifications

• Bachelor’s degree in computer science, Information Systems, Engineering or equivalent.
• 8+ yrs experience supporting discovery, clinical, regulatory, medical organizations
• Experience in the pharmaceutical/biotech industry strongly preferred
• Hands on working knowledge of Veeva systems

Responsibilities

• Understand business processes, requirements and data flows with stakeholders
• Create and update software lifecycle documentation
• Partner with cross-functional teams including R&D, Infrastructure, Validation, QA, Info Security, vendors
• Develop and manage vendor relationships, coordinating configurations, upgrades, releases, requests and support
• Lead data migration projects across the R&D organization
• Analyze gaps and opportunities for process improvements
• Coordinate issue resolution with internal and external technical support
• Prioritize tasks between strategic initiatives, releases and daily activities
• Ensure adherence to regulatory requirements, cybersecurity standards, SOPs
• Build strong relationships between business and IT
• Lead and influence cross-functional collaboration
• Oversee vendor relationships for implemented systems
• Ensure FDA computer systems validation compliance

Skills

Veeva systems experience

GxP compliance

Data analysis

Linux scripting

Effective communication

Education

Bachelor’s degree in CS/IS/Engineering

Tools

Veeva systems

AWS

Job description

Job Description

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.

Responsibilities

• 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, Info Security, vendors
• Develop and manage vendor relationships, coordinating configurations, upgrades, releases, request management and support activities
• Lead data migration projects as needed across 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
• Effectively lead, collaborate and influence working with cross-functional teams
• Oversee vendor relationships for implemented systems and solutions
• Ensure adherence to FDA computer systems validation compliance

Qualifications

Minimum Education and Experience:

• Bachelor’s degree in computer science, Information Systems, Engineering or equivalent
• 8+ yrs experience supporting discovery, clinical, regulatory, medical organizations
• Experience in the pharmaceutical/biotech industry strongly preferred
• Hands on working knowledge of Veeva systems

Technical Knowledge/Skills Needed:

• Investigates new technologies (and/or changes to existing technologies)
• Good understanding of system integrations, automation, data flows, AI tools, LLMs
• Understanding of statistical data analysis and visualization platforms
• Experience working within a GxP regulated environment
• Working knowledge of Linux platform and some scripting
• AWS experience is helpful

Core Competencies:

• Partner with vendors, external and internal stakeholders to support solution design and delivery
• Good verbal and written communication skills to effectively express ideas, provide updates to technical and non-technical audiences
• Actively Listen, value all opinions and facilitates open discussion across all functions
• Problem solving skills to understand and troubleshoot issues
• Displays flexibility and creativity in problem solving and meeting work assignments while ensuring compliance with policies and procedures

Travel Requirements

• No business travel expected

About Us

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.

The annual base salary for this position ranges from $120,000 to $140,000. 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

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. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.