Sr Systems Analyst II, R&D Systems
Alkermes
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.
Job description
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
Requirements
- 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
- 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
- Good verbal and written communication skills
- Problem solving skills
Benefits
- Performance pay bonus
- Competitive benefits package
- Hybrid workplace model
Company overview
Alkermes plc is a global biopharmaceutical company specializing in neuroscience-focused medicines for psychiatric and neurological disorders. Founded in 1987 and headquartered in Dublin, Ireland, the company maintains a significant research and development center in Waltham, Massachusetts, and a manufacturing facility in Wilmington, Ohio. Alkermes has established itself as a leader in developing treatments for complex conditions including schizophrenia, bipolar I disorder, alcohol dependence, and opioid dependence. The company's portfolio includes proprietary commercial products such as Lybalvi (olanzapine/samidorphan), Aristada (aripiprazole lauroxil), and Vivitrol (naltrexone), alongside a robust pipeline of clinical and preclinical candidates targeting neurological disorders like narcolepsy and idiopathic hypersomnia. With approximately 1,800-2,100 employees worldwide, Alkermes combines deep neuroscience expertise with sophisticated development capabilities to address traditionally overlooked or stigmatized conditions, maintaining a patient-centered approach to drug development and commercialization.