Sr Systems Analyst, IT Clinical Regulatory Medical

Alkermes

5d•Remote

About The Position

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.

Requirements

Bachelor’s degree in Computer Science, Information Systems, Engineering or equivalent
5-8 yrs experience supporting discovery, clinical, regulatory, medical organizations
Hands on working knowledge of Veeva systems
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
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

Nice To Haves

Experience in the pharmaceutical/biotech industry strongly preferred
AWS experience is helpful

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, 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