Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter’s employees are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.
The primary responsibility is to manage the information submitted to government agencies globally (such as ClinTrial.gov, EudraCT and EudaMed) to meet clinical trial disclosure requirements. These will include clinical trials with a focus on device, drug and combination products conducted both regionally and globally in accordance with applicable Baxter Clinical Operations procedures, ICH GCP Guidelines, and applicable local regulations.
Essential Duties and Responsibilities
- Understand global regulatory requirements for clinical trial disclosure
- Serve as work instruction and associated forms owner for clinical trial disclosure requirements globally
- Assist study teams in determining clinical trial disclosure requirements for each clinical trial
- Complete protocol registrations in all required governmental databases
- Maintain and update registrations in all required governmental databases
- Post results as required to all required governmental databases
- Facilitate quarterly clinical trial disclosure meetings with Clinical Operations
- Serve as clinical trial disclosure SOP owner
- Process developer for Clinical Operations interface with global clinical trial disclosure requirements
- Provide subject matter expertise and training materials and presentations for clinical study teams
Education and Experience
- Has working knowledge and familiarity with ClinicalTrials.gov, EudraCT and EudaMed
- An enthusiasm to further develop regulatory knowledge of clinical trial disclosure requirements globally
- Excellent verbal and written communication skills required. Interpersonal and organizational skills a must
- Ability to multitask with a strong attention to detail
- Working knowledge of common office and scientific computer programs such as Microsoft Word, Excel and Project
- Must demonstrate leadership skills in order to guide and manage company commitments to clinical trial disclosure
- Flexibility to work in a global environment and communicate effectively across different time zones and diverse regulatory environments
- Bachelor’s Degree + 5 years pharmaceutical and/or device clinical development experience including clinical trial disclosure activities
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.