Senior Specialist - Global Regulatory Operations, Systems Support
VIATRIS BV
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Company: Mylan Inc.
Job title: Senior Specialist, Global Regulatory Operations Systems Support
Location: Canonsburg, Pennsylvania
Duties: Work with the Global Regulatory Operational Informatics group in the creation of business intelligence tools for processing, analyzing, and aggregating complex data sets. Produce reports and metrics for consumption by a variety of business units, while ensuring compliance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes. Compare and integrate data sets from a variety of systems and spreadsheets to present report findings and future operation strategies. Design and develop business intelligence tools to make the consumption of information easier for regulatory users across Mylan’s global platforms. Evaluate submission tracking questions, metrics, reports and other system-related information. Analyze, data mine and model historical submission activities to track trends, identify atypical behavior, predict future approval dates, and provide a baseline for operating metrics. Assist with system compliance checks across Mylan’s various regulatory systems. Identify process gaps, best practices, and internal opportunities for increased efficiencies and standardization, particularly around automation via the use of technology. Analyze and compare data in the Global Application Tracking System including applications, supplements, amendments, patents and the chronology and transaction history against other relevant data sources. Collaborate with Regulatory Affairs personnel to socialize proposed changes and ensure input from all stakeholders. Perform research on required topics to help understand the regulatory requirements related to assigned projects. Telecommuting permitted from anywhere within the United States.
Requirements: Bachelor’s degree or foreign equivalent in Computer Science, Information Technology, Computer Engineering, or a related field, and 3 years of experience in the position offered or related, including 3 years of experience with: working with relational database systems and object oriented-programming languages including Django Web Development Framework, Microsoft SQL Server, Python, and related packages; using business intelligence tools including Django Web Development Framework, Python and related packages for processing, analyzing, and aggregating complex data sets related to regulatory affairs within the pharmaceutical industry; applying knowledge of applicable federal and state regulatory laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes within the pharmaceutical industry; and performing web application development including Django Web Development Framework, Python and related packages (pandas, beautiful soup), JavaScript, AJAX, Bootstrap, CSS, HTML, and Datatables.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
#LI-Remote
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Senior Specialist - Global Regulatory Operations, Systems Support
VIATRIS BV
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Company: Mylan Inc.
Job title: Senior Specialist, Global Regulatory Operations Systems Support
Location: Canonsburg, Pennsylvania
Duties: Work with the Global Regulatory Operational Informatics group in the creation of business intelligence tools for processing, analyzing, and aggregating complex data sets. Produce reports and metrics for consumption by a variety of business units, while ensuring compliance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes. Compare and integrate data sets from a variety of systems and spreadsheets to present report findings and future operation strategies. Design and develop business intelligence tools to make the consumption of information easier for regulatory users across Mylan’s global platforms. Evaluate submission tracking questions, metrics, reports and other system-related information. Analyze, data mine and model historical submission activities to track trends, identify atypical behavior, predict future approval dates, and provide a baseline for operating metrics. Assist with system compliance checks across Mylan’s various regulatory systems. Identify process gaps, best practices, and internal opportunities for increased efficiencies and standardization, particularly around automation via the use of technology. Analyze and compare data in the Global Application Tracking System including applications, supplements, amendments, patents and the chronology and transaction history against other relevant data sources. Collaborate with Regulatory Affairs personnel to socialize proposed changes and ensure input from all stakeholders. Perform research on required topics to help understand the regulatory requirements related to assigned projects. Telecommuting permitted from anywhere within the United States.
Requirements: Bachelor’s degree or foreign equivalent in Computer Science, Information Technology, Computer Engineering, or a related field, and 3 years of experience in the position offered or related, including 3 years of experience with: working with relational database systems and object oriented-programming languages including Django Web Development Framework, Microsoft SQL Server, Python, and related packages; using business intelligence tools including Django Web Development Framework, Python and related packages for processing, analyzing, and aggregating complex data sets related to regulatory affairs within the pharmaceutical industry; applying knowledge of applicable federal and state regulatory laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes within the pharmaceutical industry; and performing web application development including Django Web Development Framework, Python and related packages (pandas, beautiful soup), JavaScript, AJAX, Bootstrap, CSS, HTML, and Datatables.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
#LI-Remote