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Senior GPS Systems Manager
Who We Are
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
How you'll contribute
United Therapeutics Corporation seeks a Senior GPS Systems Manager in Silver Spring, MD to Plan, define and execute the high-level computer applications systems analysis necessary to maintain global pharmacovigilance (PV) computer and data systems for the management of the company's safety data and to ensure the security and integrity of this safety data. Plan and implement optimal systems solutions for the organization's drug safety and PV systems to ensure compliance and data integrity, while also implementing improvements as a result of automating certain IT processes to increase efficiencies and reduce outsourcing costs. Analyze information-technology systems needs and translate these business requirements into detailed technical requirements. Perform system support and configuration planning, and/or application modifications in a compliant manner. Develop, maintain, and oversee full implementation of relevant procedural documents, and templates, including but not limited to SOPs. Provide technical workarounds to the systems engineering and development teams to resolve complex system gaps. Generate and review all data extraction strategies including SAE reconciliation, inspection/audit reports, trending analysis, and other routine business reports. Ensure the compliance of PV computer systems and databases as it relates to regulatory inspections and audits. Ensure relevant data-systems security checks are performed in timely manner for all safety systems. Work with GPS & PV systems vendors to ensure that all safety systems and database are appropriately patched in timely manner. Plan and execute ad hoc database pulls and/or custom report developments to meet business requirements. Will be responsible & accountable for the maintenance of safety applications & tools (data analytics, data entry, medical coding, systems integrity, configuration support, systems compliance, e2b support etc.). Serve as a key contributor for the company's GPS & PV function ensuring business application systems continuity. Plan and execute integrations, validation, and support User Acceptance Testing(s). Propose improvements/efficiency gains for business processes and support process excellence using a computer information systems perspective. Position to be located in Silver Spring, MD with remote employment within the United States acceptable.
Position requires a Bachelor's degree or foreign equivalent in Computer Science, Computer Engineering or Software Engineering, and 9 years of experience in the position or in a related computer systems analyst, computer programmer or software engineer position. In the alternative, the employer will accept a Master's Degree or foreign equivalent in Computer Science, Computer Engineering or Software Engineering, and 7 years of experience in the position or in a related computer systems analyst, computer programmer or software engineer position. Must have 7 years of experience conducting computer and systems analysis to support the management of Drug Safety Systems; 7 years of programming experience employing PL/SQL, C++, MS .Net Framework; 3 years of experience optimizing the use of the Argus Safety software platform; and, 3 years of experience executing Business Intelligence reporting employing either Cognos, Business Objects, or OBIEE.
Offered wage: 153,000 - 208,500.00 w/ standard benefits.
#LI-DNI AND #DE-DNI
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.