Senior Systems Analyst (R&D IT – Clinical, Regulatory, Medical)

POSITION 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.

• 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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