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Specialist Information Systems (IS) Business Systems Analyst - Regulated Content Management - Full-time / Part-time
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Tampa, FL Tampa, Florida |
About this job
Amgen is seeking a Specialist Information Systems (IS) Business Systems Analyst of Regulated Content Management to join our Corporate Functions Data and Analytics group and will report to will report to the Senior Manager Information Systems – Enterprise Regulated Data. The Specialist will be based out of Amgen’s Capability Center in Tampa, FL. At Amgen our missing is simple: To serve patients. Our new Tampa Capability Center provides essential services that enable us to better pursue this mission. This state-of-the-art center serves as a base for finance, information systems, and human resources professionals to make a meaningful impact at one of the world’s leading biotechnology companies.
The Specialist IS Business Systems Analyst - Regulated Content Management will support various functions and applications within Regulated Content Management and work with stakeholders in Research and Development IS and Enterprise IS in order to define and implement strategic initiatives and applications while adhering to Amgen standards, policies and procedures. The Specialist will be part of the Enterprise IS team responsible for delivering systems in support of Regulated Document Management. Additionally, the Incumbent will act as an active thought partner and application visionary who shapes the technology demand among the business community while supporting the accountable Service Owner during agency inspections or internal audits.
Advanced Analytic and Knowledge Management (AKM) services include Advanced Analytics and Data Integration, Big Data technology services, Information Discovery and Search, Information Architecture, Knowledge Management (KM) and Regulated Content Management.
Key Activities for the Specialist include:
Partnering with the Service Owner to create and maintain a service to achieve the strategic vision
Analyzes documents and tests program development, logic, process flows and specifications
Partners with business partners to conduct user acceptance testing
Develops user manuals to describe application installation and operating procedures
Partners with business and technology partners to elicit, analyze, translate, and document business requirements into functional and non-functional requirements
Prepares for and ensures that documentation stands up to audits and inspections; provides further documentation and provides system ownership and support of critical applications
Maintains and updates inspection readiness for critical applications, including inspection readiness playbook, periodic assessments (data integrity, security, system compliance)
Develops test script protocols in support of projects
Provides Installation and Operational Qualification documents
Develops validation protocols such as Requirements and Design Specifications
Maintains and builds relationships with key business stakeholders
Escalates problems and issues to management as appropriate
Participates in proactive state of the art research and provides recommendations for continuous improvement
10% domestic travel can be expected
Basic Qualifications:
Doctorate degree
OR
Master’s degree and 3 years of Information Systems experience
OR
Bachelor’s degree and 5 years of Information Systems experience
OR
Associate’s degree and 10 years of Information Systems experience
OR
High school diploma / GED and 12 years of Information Systems experience
Preferred Qualifications:
5+ years’ experience in a Documentum / Veeva Architect / Technical Lead function
Thorough understanding of the Documentum / Veeva Product Suite including Document Management and Records Management and experience with System Development Life Cycle processes and strong demonstrated knowledge of validation and cGMP
History of analytical and troubleshooting skills and ability to understand business functionality and translate it into application requirements
Excellent understanding of business complexity and project interdependencies and ability to create compelling business cases with accurate cost and effort estimates
Intellectual curiosity and the ability to tactfully question business partners across functional areas and ability to partner with Software Engineers and Quality Analysts to identify course of resolutions
Strong understanding of basic system engineering, object-oriented design, information risk and security guidelines, and architecture standards
Comprehensive understanding of the various software development lifecycles (i.e., Agile, Waterfall, etc.) and understanding of modeling techniques, such as unified modeling language, etc.
Solid foundation of cGMP, including change control processes, 21 CFR Part 11, validation, and ability to write validation protocols such as Validation Plans, Requirements Specifications, Design Specifications, IQs, OQs, and be able to execute the validation protocols
Outstanding written and verbal communication skills and experience working with computer systems from inception to deployment to maintenance
Biotechnology, pharmaceutical, or healthcare experience
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
The invaluable contributions of our talented Tampa team will help us develop the vital and innovative medicines that treat serious illness and unmet medical needs around the globe.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
The Specialist IS Business Systems Analyst - Regulated Content Management will support various functions and applications within Regulated Content Management and work with stakeholders in Research and Development IS and Enterprise IS in order to define and implement strategic initiatives and applications while adhering to Amgen standards, policies and procedures. The Specialist will be part of the Enterprise IS team responsible for delivering systems in support of Regulated Document Management. Additionally, the Incumbent will act as an active thought partner and application visionary who shapes the technology demand among the business community while supporting the accountable Service Owner during agency inspections or internal audits.
Advanced Analytic and Knowledge Management (AKM) services include Advanced Analytics and Data Integration, Big Data technology services, Information Discovery and Search, Information Architecture, Knowledge Management (KM) and Regulated Content Management.
Key Activities for the Specialist include:
Partnering with the Service Owner to create and maintain a service to achieve the strategic vision
Analyzes documents and tests program development, logic, process flows and specifications
Partners with business partners to conduct user acceptance testing
Develops user manuals to describe application installation and operating procedures
Partners with business and technology partners to elicit, analyze, translate, and document business requirements into functional and non-functional requirements
Prepares for and ensures that documentation stands up to audits and inspections; provides further documentation and provides system ownership and support of critical applications
Maintains and updates inspection readiness for critical applications, including inspection readiness playbook, periodic assessments (data integrity, security, system compliance)
Develops test script protocols in support of projects
Provides Installation and Operational Qualification documents
Develops validation protocols such as Requirements and Design Specifications
Maintains and builds relationships with key business stakeholders
Escalates problems and issues to management as appropriate
Participates in proactive state of the art research and provides recommendations for continuous improvement
10% domestic travel can be expected
Basic Qualifications:
Doctorate degree
OR
Master’s degree and 3 years of Information Systems experience
OR
Bachelor’s degree and 5 years of Information Systems experience
OR
Associate’s degree and 10 years of Information Systems experience
OR
High school diploma / GED and 12 years of Information Systems experience
Preferred Qualifications:
5+ years’ experience in a Documentum / Veeva Architect / Technical Lead function
Thorough understanding of the Documentum / Veeva Product Suite including Document Management and Records Management and experience with System Development Life Cycle processes and strong demonstrated knowledge of validation and cGMP
History of analytical and troubleshooting skills and ability to understand business functionality and translate it into application requirements
Excellent understanding of business complexity and project interdependencies and ability to create compelling business cases with accurate cost and effort estimates
Intellectual curiosity and the ability to tactfully question business partners across functional areas and ability to partner with Software Engineers and Quality Analysts to identify course of resolutions
Strong understanding of basic system engineering, object-oriented design, information risk and security guidelines, and architecture standards
Comprehensive understanding of the various software development lifecycles (i.e., Agile, Waterfall, etc.) and understanding of modeling techniques, such as unified modeling language, etc.
Solid foundation of cGMP, including change control processes, 21 CFR Part 11, validation, and ability to write validation protocols such as Validation Plans, Requirements Specifications, Design Specifications, IQs, OQs, and be able to execute the validation protocols
Outstanding written and verbal communication skills and experience working with computer systems from inception to deployment to maintenance
Biotechnology, pharmaceutical, or healthcare experience
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
The invaluable contributions of our talented Tampa team will help us develop the vital and innovative medicines that treat serious illness and unmet medical needs around the globe.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.