The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are 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.
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, and other orphan diseases.
How you’ll contribute
Manage and/or assist in all Global GCP/GLP/GVP Compliance aspects with primary focus in Global Product Safety & Pharmacovigilance compliance (GVP), ensuring appropriate systems and procedures are in place to comply with applicable regulations and guidelines, United Therapeutics SOPs, and vendor contracts. Activities will include documentation review, GVP annual risk assessments (internal and external) and audit schedules set-up and budgeting, internal process audits and follow-up, external vendor and commercial partner qualification and routine audits and follow-up, PSMF contribution for GVP Compliance activities, providing guidance to Global Drug Safety, Clinical Operations, Medical Information/Medical Affairs, and Regulatory Affairs, as applicable regarding GVP compliance, and supporting GCP and GLP compliance activities and Quality Event and CAPA reviews as needed.
This is a remote position with 20-40% travel required to conduct vendor/external GVP and occasionally GCP compliance audits, as well as travel to/from the office required to participate in internal audits, team activities, etc. Travel may be between 2 days and +1 week depending on activities and locations. Audit travel may include any country conducting activities for UT, but currently includes locations in North America, Europe, Israel, and Asia.
- Manage and assist in implementing and maintaining a comprehensive risk-based GVP compliance program
- Manage and assist in completing annual risk assessments (internal and external), setting annual audit schedules and preparing the necessary GVP Compliance budget
- Manage and conduct GVP external vendor, commercial partner, and internal process audits according to United Therapeutics SOPs and within the related budget
- Provide audit reports to system/process owners and GCP/GLP/GVP Compliance Management on schedule
- Review and approve audit responses and evaluate adequacy of corrective and/or preventative actions
- Provide GVP Compliance SME support during global regulatory agency inspections and other audits of UT offices
- Identify and assist in developing standard operating procedures (SOPs) and systems needed to comply with regulatory requirements
- Responsible for maintenance of applicable sections of PSMF for which Global GVP Compliance is responsible
- Perform quality reviews of documentation in area of responsibilities, as needed
- Provide summary reports to management of audit activities
- Provide guidance to Global Product Safety & Pharmacovigilance, Clinical Operations, Medical Information/Medical Affairs, and Regulatory Affairs, as applicable regarding GVP compliance
- Assist in the coordination and conduct of functional area/departmental programs
- Crosstrain/assist in GCP and GLP Compliance related activities including audits, as needed
- Assist in GxP Compliance related activities including any systems and/or tools, as needed
- Perform other duties as assigned
For this role you will need
- Bachelor’s Degree in Arts/Sciences (BA/BS) in a science related field or
- Registered Nurse (RN)
- 5+ years of direct Pharmacovigilance/GVP experience
- Auditor Certification (i.e, ASQ, SQA) or Exam completion (ISO 9001) obtained or to be obtained during the first 6 months of UT employment as agreed with manager
- Ability to interact and communicate effectively, both verbally and in writing, with colleagues and management, both within and outside GCP/GLP/GVP Compliance, including senior management, regulatory agency personnel, vendor personnel, contracted service providers and consultants
- Working knowledge of global GVP/GCP regulations and guidelines and international regulatory practices
- Good eye for detail and commitment to seeing tasks through to completion
- Experience and comfort in working both independently and as part of a multifunctional team
- Ability to write comprehensive audit reports and summary documentation for senior management and functional areas responsible for supporting
- Proven organizational skills and strong ability to prioritize workload
- Commitment and ability to handle high workloads, stressful situations, changing priorities, and deadlines
- Working knowledge of word processing, spreadsheet, and email software
- Experience with a risk-based auditing approach to assure compliance
- Familiar with a Company Pharmacovigilance Summary Master File (PSMF) document and able to contribute towards required audit-related information
- Experience with electronic systems used to manage safety reporting (i.e., Argus, Aris G, etc.)
- Experience with Computer Systems audits/validation activities
- Willingness to conduct audits globally in-person and remotely
- 8+ years of relevant pharmaceutical industry experience
- Experience with GVP/GCP CAPAs, trending analysis, and risk analysis
- Experience with Trackwise/Trackwise Digital, Veeva, and MasterControl
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:
- Thesalary rangefor this role at a senior level is[$96k-$140k]
- This role is 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.
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