Senior GPS Systems Manager/Associate GPS Systems Director

The job details are as follows:

What We Do

United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens - having a positive impact on patients, the environment and society - will sustain our success in the long term.

We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.

Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.

In 2021, we became the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.

How you’ll contribute
Maintain and execute complex business problems to support Global Product Safety & Pharmacovigilance systems. Provide technical assistance for identifying, evaluating, developing & maintaining systems and procedures that are cost-effective, and meet user requirements.

• Manage and maintain global pharmacovigilance (PV) systems for the management of Company safety data; ensure the security and integrity of safety data
• Plan and execute on the organization's drug safety and PV systems to ensure compliance and data integrity, while also implementing improvements as a result of automating processes to increase efficiencies and reduce outsourcing costs
• Analyze system needs and translate business requirements in detailed technical requirements
• Perform system support, configurations, and/or application modifications in a compliant manner
• Provide technical workarounds to the team for complex system gaps
• Develop, maintain and oversee full implementation of relevant procedural documents, templates, including but not limited to SOPs
• Research technology trends and develop expertise in services, applications, infrastructure, analytical tools, and techniques
• Generate and review all data extraction strategies including SAE reconciliation, inspection/audit reports, trending analysis and other routine business reports
• Monitor system analysis activities; track system performance and measure capacity against organizational needs
• Ensure compliance of PV systems and database as it relates to inspections and audits
• Ensure relevant security checks are done in timely manner for all safety systems
• Work with GPS & PV systems vendor ensuring all safety systems and database are appropriately patched in timely manner
• Act as a liaison between GPS & PV different functions, other departments and external vendors
• Perform ad hoc database pulls and/or custom report developments to meet business need
• Responsible & accountable for management 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 GPS & PV function ensuring business continuity
• Plan and execute integrations, validation and support User Acceptance Testing(s)
• Lead or participate in cross-functional projects, including PV internal & external projects
• Propose improvements/efficiency gains for business processes and support process excellence using a technical perspective
• Perform other duties as assigned to support GPS & PV functions (existing projects, new initiatives & projects required to support UT demands)

For this role you will need

Minimum Requirements for Senior GPS Systems Manager

• Bachelor’s Degree in Arts/Sciences (BA/BS) in Computer Science or Information Technology or Master’s degree (MA/MS/MBA) in Computer Science or Information Technology
• 10+ years of experience in programming (PL/SQL, C++, .Net, BI reporting) with a Bachelor's degree or 8+ years of experience in programming (PL/SQL, C++, .Net, BI reporting) with a Master's degree
• 7+ years of experience in implementation & management of Drug Safety Systems
• Argus Core safety, BI (Cognos, Business Objects, OBIEE, Spotfire etc.) Argus, affiliate, Argus Japan, Argus insight, Argus interchange, developing business reports, ensuring E2B & system integrity & compliance
• Strong analytical and problem solving skills
• Ability to deliver group training on technical development and systems configurations
• Excellent oral and written communication skills

Minimum Requirements for Associate GSP Systems Director

• Bachelor’s Degree in Arts/Sciences (BA/BS) in Computer Systems or Information Technology or Master’s degree (MA/MS/MBA) In Computer Systems or Information Technology
• 12+ years of experience in programming (PL/SQL, C++, .Net, BI reporting) with a Bachelor's degree or 10+ years of experience in programming (PL/SQL, C++, .Net, BI reporting) with a Master's degree
• 8+ years of experience in implementation & management of Drug Safety Systems
• Advance knowledge of MS Office (Word, Excel, PowerPoint, Access) DataLoader
• Ability to think strategically, outside of the box and provide innovative technical solutions
• Proficiency in understanding global regulatory requirements, guidelines and industry best practices and ability to transform them into compliant PV solutions
• Ability to build relationships and work well cross-functionally
• Strong analytical and problem solving skills
• Argus Core safety, BI (Cognos, Business Objects, OBIEE, Spotfire etc.) Argus, affiliate, Argus Japan, Argus insight, Argus interchange, developing business reports, ensuring E2B & system integrity & compliance
• Proactive, self-starter with ability to work under minimal direction
• Excellent oral and written communication skills
• Ability to deliver group training on technical development and systems configurations
• Knowledge of Agile development methodologies
• Strong hands on experience on SQL, PL/SQL
• Good understanding of Empirica Signal Datamart and application functionality, should be able to resolve ETL issues and configure custom ETL logics
• Able to negotiate and build consensus for plans and priorities and develop effective working relationship through collaboration

Preferred Qualifications

• Experience in Argus safety database
• Strong knowledge of relational databases, concepts of Data warehousing, SQL,PL/SQL
• Good understanding of Software Development Life Cycle methodologies
• Good understanding of C,C++, .Net, Python, Java scripts etc.

At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.

Applicable to Colorado Applicants Only:

• The salary range for the Senior Manager role is$122,000 - 1$74,000. The salary range for the Associate Director role is$132,000 - $188,000.
• Both roles are also eligible for the Company’s incentive plan.
• The Company also offers benefits as outlined to eligible employees: https://www.unither.com/careers-benefits.html
• The hourly or salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, seniority, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range is only applicable for jobs to be performed in Colorado. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

United Therapeutics offers a comprehensive total rewards package, along with additional services and amenities intended to maximize convenience and work/life balance.

While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities