Job description
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
Involved in all aspects of clinical QA activities, including documentation review; internal process audits and external site and vendor audit; follow-up and CAPA management; providing guidance to clinical operations, data management & statistics, and drug safety; ensuring appropriate systems and procedures are in place to comply with applicable regulations and guidelines, Company SOPs, and study requirements.
Manage the implementation and maintenance of a comprehensive GCP compliant quality program- Review audit responses and evaluate adequacy of corrective actions/preventative actions (CAPAs)
- Assist with regulatory agency and other audits/inspections of the Research Triangle Park office, Silver Spring office, and clinical sites
- Identify and develop standard operating procedures (SOPs) and systems needed to comply with regulatory requirements
- Perform quality assurance reviews of Clinical Study Reports and other study documentation as necessary
- Perform document record review, including general study files, site specific study files, clinical and pharmacological, etc.
- Develop clinical/departmental training programs
- Review and evaluate UT procedures and policies to ensure consistency with pertinent government regulations and guidelines
- Maintain expert knowledge of regulations, UT procedures, auditing, and quality principles
- Represent quality on at least one multi-functional product development project team and report on-going progress to the auditing team
- Assist with external site and vendor audits as requested by Corporate Compliance
- Deal effectively and diplomatically with sites, service providers, and other UT departments
- Perform other duties as assigned
For this role you will need
Minimum Requirements
- Bachelor’s Degree in Arts/Sciences (BA/BS) in a technical or scientific related field
- 8+ years of relevant pharmaceutical industry experience, with direct GCP experience
- Experience with clinical CAPAs, trending analysis, and audits
- Demonstrated expertise in and knowledge regarding International Conference on Harmonization (ICH) Good Clinical Practice Guidelines and EudraLex - Volume 10 Clinical trials guidelines (EU)
- Working knowledge of word processing, spreadsheet, and email software
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.
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
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