Sr Systems Analyst II, R&D Systems

Posted Yesterday
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Waltham, MA, USA
In-Office
120K-140K Annually
Senior level
Biotech • Pharmaceutical
The Role
Supports R&D IT systems for development, clinical, regulatory, medical, and pharmacovigilance teams in a GxP-regulated pharmaceutical environment. Responsibilities include requirements elicitation, system lifecycle documentation, vendor management, data migration, integrations, issue resolution, solution improvement, and cross-functional delivery. The role ensures FDA computer systems validation, cybersecurity, regulatory, and SOP compliance while supporting Veeva and other R&D platforms.
Summary Generated by Built In

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

 

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. 

 

#LI-AH1

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.

Skills Required

  • Bachelor's degree in Computer Science, Information Systems, Engineering, or equivalent
  • 8+ years of experience supporting discovery, clinical, regulatory, or medical organizations
  • Experience in the pharmaceutical or biotech industry
  • Hands-on working knowledge of Veeva systems
  • Understanding of system integrations, automation, data flows, AI tools, and LLMs
  • Understanding of statistical data analysis and visualization platforms
  • Experience working in a GxP-regulated environment
  • Working knowledge of Linux and some scripting
  • AWS experience
  • Ability to work onsite at the Waltham, Massachusetts office at least three days per week
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The Company
HQ: Waltham, MA
2,400 Employees

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

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