Alkermes

Sr Systems Analyst, IT Clinical Regulatory Medical

Alkermes  •  $105k - $119k/yr  •  Waltham, MA (Onsite)  •  1 month ago
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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.

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

Minimum Education and Experience:

  • Bachelor’s degree in Computer Science, Information Systems, Engineering or equivalent

  • 5-8 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

  • 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 $105,000 to $119000. 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

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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.

Alkermes

About Alkermes

At Alkermes, we apply our deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. We have 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. Our patient-inspired science, integrated research strategy, sophisticated development capabilities and specialized commercial infrastructure enable us to pursue the development and commercialization of innovative new medicines, including those for people with conditions that have traditionally been overlooked or stigmatized.

Our greatest strengths at Alkermes are our people and our inherent empathy for patients, families and caregivers. Neurological and psychiatric disorders strike people at the core of who they are and impact many facets of their lives. We work with urgency to develop new treatment options for people living with these conditions.

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. We remain committed to patient engagement, responsible and sustainable operations, and equitable access to quality treatment.

Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio.

See our Community Guidelines: https://www.alkermes.com/social-community-guidelines

Industry
Biotech & Life Sciences
Company Size
1,001-5,000 employees
Headquarters
Dublin, IE
Year Founded
1987
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