United Therapeutics Senior Clinical Supply Specialist in Silver Spring, Maryland
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
The Senior Clinical Supply Specialist (Sr. CSS) participates in the development of packaging & labeling design & fulfillment strategies for Investigational Product (IP) to ensure IP manufacture occurs in a timely manner & clinical trial First-Patient-In (FPI) dates are met.
Role Purpose/Expected Outcomes
Attend & participate in study-related meetings to build cross-functional relationships, gather information on study progress & share information on clinical trial material (CTM) status
Review CTM shipment requests from Clinical/CRO for accuracy & completeness prior to forwarding to packaging vendor for processing
Maintain oversight of inventory of packaged/labeled CTM & related supplies
Update timeline & milestone information in current tracking tool(s) (electronic &/or hard copy) for communication to Quality Assurance (QA), CSC management & associated vendors
Maintain current, accurate & complete files (hard copy & electronic) of all study documentation related to CTM
Coordinate & document activities related to creation of labels for CTM including translations, approvals (QA, Regulatory, etc.), printing & receipt at packaging vendor
Coordinate & document activities related to the packaging/labeling of CTM including communicating with the packaging vendor, overseeing batch record production & review, scheduling of production run at vendor, & review & approval of executed batch records by QA
Assist with preparing presentations for Investigator Meetings, CRA training, site initiations or other similar training situations
Coordinate & document activities related to the production of CTM manuals, distribution protocols, returns protocols, accountability documentation, returns documentation & other documentation related to CTM & used by the distribution vendor or clinical site
Maintain oversight of the CTM returns process (including stock recovery activities) in conjunction with the CRA to document full reconciliation of CTM used in trials
Review vendor invoices for accuracy
Coordinate & document activities surrounding complaints received from sites or vendors
Assist in preparation & maintenance of departmental SOPs, working practice documents (WPDs) & other procedural documentation
For this role you will need
Requires a BA/BS in any discipline (prefer scientific discipline) with 4 years direct CTM experience or 5 years related experience
Prefer experience in the Biotechnology &/or Pharmaceutical industry & some project management experience
Familiarity with cGMP/GCP/ICH guidelines
Must be highly organized & possess excellent attention to detail
Must be a self-starter with strong oral, written, & interpersonal communication skills as well as a proven ability to work in a team environment
Proven ability to juggle multiple tasks with varying priorities to meet timelines
Proven ability to recognize activities or events that may critically affect the availability of CTM or the conduct of clinical trials & act on or pass that information to appropriate level of management
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.