United Therapeutics Clinical Training and Standards Specialist I/II in Durham, North Carolina

The Job Details are as follows:

What we do

United Therapeutics is a biotechnology company that focuses on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.

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.

How you’ll contribute

Support the Global Clinical Training and Standards department with the management of training matrices, materials and delivery. Assist with development and management of Clinical Standard Operating Procedures (SOPs) and quality metrics.

  • Support GxP Training with updating and maintaining Learning Management System (LMS) with Clinical requirements including processing course descriptions, submission of clinical training materials and recorded presentations, and tracking training requests

  • Assist in managing the content of clinical materials within the LMS

  • Organize department meetings, training activities and presentations

  • Participate and represent the department on various department teams and task forces

  • Track and manage Inspection Readiness program, including maintaining schedule for periodic Quality Control visits by the Manager, Clinical Quality Control and assisting in tracking of audit findings from other UT groups (QA) or external groups (regulatory authorities)

  • Maintain training schedule and repository for materials

  • Manage department files and those within the Document Management System

  • Capture department metrics and assist in data analysis

  • Assist in revising, facilitating development, and tracking of SOPs, policies, and associated forms

  • Perform other duties as assigned

For this role you will need

  • BA/BS degree; scientific field strongly preferred

  • 2+ years of relevant clinical research experience for Specialist I level; 4+ years of relevant clinical research experience for Specialist II level

  • Experience writing and revising SOPs and department processes

  • Experience training and mentoring clinical research staff

  • Strong written/oral communication and presentation skills.

  • Excellent time management and organizational skills with strong attention to detail and accuracy

  • Ability to multitask, prioritize, and creatively problem-solve in a fast-paced environment

  • Working knowledge of US FDA, GCP, EU and local regulations and clinical research process.

  • Ability to work independently and as part of a multi-functional team.

  • Proficiency with Microsoft Office, Learning Management Systems (LMS), eTMF, and web conferencing systems (e.g. WebEx, GoToMeeting, Skype)

  • Ability to travel up to 10% as needed

Preferred Qualifications

  • Experience with systems such as MasterControl, Trackwise, CTMS, OneDrive, and SharePoint strongly preferred

Life as a Unitherian

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.

We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level of job performance and provides state of the art facilities to flourish. This is what makes United Therapeutics a stimulating place to work.

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

United Therapeutics currently has 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 employees can be found collaborating across the United States, Europe and Asia.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high level job performance, and provide state of the art facilities in which to flourish. This is what makes United Therapeutics a stimulating place to work. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation, and achievement into success.