1+ months

Associate Director, IT Business Partner

ACADIA Pharmaceuticals
Princeton, NJ 08540
  • Job Code
    112043599

ACADIA Pharmaceuticals

U.S. Equal Opportunity Employment Information
In keeping with our commitment to the community in which we do business, and in compliance with state and federal law, ACADIA is an equal opportunity employer. Our employment policies and procedures ensure that we are committed to providing equal employment opportunities in all aspects of employment without unlawful regard to race, color, religion, national origin, ancestry, sex, sexual orientation, age, veteran's status, marital status, medical condition, and physical or mental disability. As an equal opportunity employer, we hire without consideration to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, veteran status or disability. We invite you to complete the optional self-identification fields below used for compliance with government regulations and record-keeping guidelines.


Location:
Princeton, NJ


This position will serve as a technology partner in the R&D domain as well as the local New Jersey site lead for IT, providing technology leadership, operational support and project management for key projects. The IT Business Partner will work both on projects, as a critical team member, and with operational teams to help ease the introduction of new technologies and to maintain and further improve upon operational processes. The IT Business Partner will help define and document key processes, requirements, knowledge articles, and user documentation.

Primary Duties & Responsibilities:
  • Act as IT site lead for local New Jersey office by conducting, coordinating, and communicating IT operational plans (enterprise, back-office and infrastructure)
  • Act as operational lead for existing R&D systems including holding recurring operational meetings with business partners and vendors, tracking and evaluating change requests, initiating change controls for implementation of changes, coordinating routine system patches and escalating issues as appropriate
  • Work with Lead IT Business Partner for R&D to establish and enhance key relationships with business stakeholders and provide input to R&D systems roadmap
  • Work with Business and IT Business Partners to help define and document R&D business processes and requirements including, but not limited to, data flow, data storage, application usability, infrastructure, reporting and analytics
  • Support IT project management in the implementation of technology solutions according to ACADIA's IT governance processes, including intake assessment and standard PMO reporting
  • Facilitate RFP initiatives for evaluating new technology solutions
  • Perform vendor management activities such as establishing contracts (e.g., NDA, MSA, SOW) and managing ongoing licensing and renewals
  • Create training materials, "How To," and knowledge items to ease user adoption of new technology
  • Define standard operating procedures and perform periodic review activities for R&D systems
  • Facilitate UAT with business partners
  • Define, coordinate and/or execute system integration testing as needed
  • Triage and facilitate resolution of application issues and escalate to vendor support as needed
  • Conduct source systems data quality analysis as needed
  • Perform computer systems validation activities adhering to 21 CFR Part 11 guidelines
  • Provide configuration support for key R&D systems, if required

Education/Experience/Skills:

Bachelor's degree in Information Systems or equivalent technical discipline. An equivalent combination of relevant education and applicable job experience may be considered. A minimum of 10 years progressively responsible experience in the pharmaceutical industry with a focus on R&D systems and processes as well as computer system validation. Must possess:
  • Experience working in a regulated environment following GxP processes
  • Solid domain knowledge of business processes and related data types in R&D functional areas (Pre-clinical, clinical development, clinical operations, regulatory, pharmacovigilance, biostatistics and data management) to support technology solutions
  • Ability to be highly organized, self-motivated with the capability to prioritize projects and workload
  • Skilled at effectively leading IT projects with cross functional team effort and organizing resources to achieve project goals
  • Adaptability to quickly and proactively implement change initiatives
  • Excellent attention to detail
  • Excellent interpersonal and communications skills, including tact, diplomacy and flexibility
  • Excellent skills in defining and documenting processes, requirements, and training materials
  • Experience documenting SOPs and other controlled documents
  • Experience with change management and computer systems validation processes
  • Experience with operational systems support for key R&D systems providing issue resolution through internal resources and vendor support
  • Experience with standard systems development life cycle (SDLC) and SaaS deployment models
  • Familiarity with EDC, IRT, eTMF, CTMS, SAS, Argus, clinical analytics, safety, LMS, QMS and/or regulatory systems
  • The following considered a plus:
  • Familiarity with global GCP, GVP and GLP regulations
  • Experience in clinical and regulatory systems
  • Experience supporting clinical trials in an outsourced model (working with CROs)
  • PMP certification

PI112043599

</br><b>ACADIA Pharmaceuticals</b></br></br>U.S. Equal Opportunity Employment Information <br> In keeping with our commitment to the community in which we do business, and in compliance with state and federal law, ACADIA is an equal opportunity employer. Our employment policies and procedures ensure that we are committed to providing equal employment opportunities in all aspects of employment without unlawful regard to race, color, religion, national origin, ancestry, sex, sexual orientation, age, veteran's status, marital status, medical condition, and physical or mental disability. As an equal opportunity employer, we hire without consideration to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, veteran status or disability. We invite you to complete the optional self-identification fields below used for compliance with government regulations and record-keeping guidelines.<br/><br/><bAssociate Director, IT Business Partner</b><br/>Location:<br>Princeton, NJ<br/><br/><br>This position will serve as a technology partner in the R&D domain as well as the local New Jersey site lead for IT, providing technology leadership, operational support and project management for key projects. The IT Business Partner will work both on projects, as a critical team member, and with operational teams to help ease the introduction of new technologies and to maintain and further improve upon operational processes. The IT Business Partner will help define and document key processes, requirements, knowledge articles, and user documentation. <br><br><u><strong>Primary Duties & Responsibilities:</strong></u><br> <ul> <li>Act as IT site lead for local New Jersey office by conducting, coordinating, and communicating IT operational plans (enterprise, back-office and infrastructure) </li> <li>Act as operational lead for existing R&D systems including holding recurring operational meetings with business partners and vendors, tracking and evaluating change requests, initiating change controls for implementation of changes, coordinating routine system patches and escalating issues as appropriate</li> <li>Work with Lead IT Business Partner for R&D to establish and enhance key relationships with business stakeholders and provide input to R&D systems roadmap</li> <li>Work with Business and IT Business Partners to help define and document R&D business processes and requirements including, but not limited to, data flow, data storage, application usability, infrastructure, reporting and analytics</li> <li>Support IT project management in the implementation of technology solutions according to ACADIA's IT governance processes, including intake assessment and standard PMO reporting</li> <li>Facilitate RFP initiatives for evaluating new technology solutions</li> <li>Perform vendor management activities such as establishing contracts (e.g., NDA, MSA, SOW) and managing ongoing licensing and renewals </li> <li>Create training materials, "How To," and knowledge items to ease user adoption of new technology </li> <li>Define standard operating procedures and perform periodic review activities for R&D systems</li> <li>Facilitate UAT with business partners</li> <li>Define, coordinate and/or execute system integration testing as needed</li> <li>Triage and facilitate resolution of application issues and escalate to vendor support as needed</li> <li>Conduct source systems data quality analysis as needed</li> <li>Perform computer systems validation activities adhering to 21 CFR Part 11 guidelines</li> <li>Provide configuration support for key R&D systems, if required</li> </ul> <br><u><strong>Education/Experience/Skills:</strong></u><br><br>Bachelor's degree in Information Systems or equivalent technical discipline. An equivalent combination of relevant education and applicable job experience may be considered. A minimum of 10 years progressively responsible experience in the pharmaceutical industry with a focus on R&D systems and processes as well as computer system validation. Must possess:<br> <ul> <li>Experience working in a regulated environment following GxP processes</li> <li>Solid domain knowledge of business processes and related data types in R&D functional areas (Pre-clinical, clinical development, clinical operations, regulatory, pharmacovigilance, biostatistics and data management) to support technology solutions</li> <li>Ability to be highly organized, self-motivated with the capability to prioritize projects and workload</li> <li>Skilled at effectively leading IT projects with cross functional team effort and organizing resources to achieve project goals</li> <li>Adaptability to quickly and proactively implement change initiatives</li> <li>Excellent attention to detail</li> <li>Excellent interpersonal and communications skills, including tact, diplomacy and flexibility</li> <li>Excellent skills in defining and documenting processes, requirements, and training materials</li> <li>Experience documenting SOPs and other controlled documents</li> <li>Experience with change management and computer systems validation processes </li> <li>Experience with operational systems support for key R&D systems providing issue resolution through internal resources and vendor support</li> <li>Experience with standard systems development life cycle (SDLC) and SaaS deployment models</li> <li>Familiarity with EDC, IRT, eTMF, CTMS, SAS, Argus, clinical analytics, safety, LMS, QMS and/or regulatory systems</li> <li>The following considered a plus:</li> <li>Familiarity with global GCP, GVP and GLP regulations</li> <li>Experience in clinical and regulatory systems</li> <li>Experience supporting clinical trials in an outsourced model (working with CROs)</li> <li>PMP certification </li> </ul> <img src="https://analytics.click2apply.net/v/j7nAXxT8BkPbFRZ6uxyPa"> <p>PI112043599</p>

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Posted: 2019-07-18 Expires: 2019-08-18

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Associate Director, IT Business Partner

ACADIA Pharmaceuticals
Princeton, NJ 08540

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