Associate, Clinical Trials

Zydus Therapeutics Inc. • Hopewell Township, NJ

145d

About The Position

Zydus Therapeutics is a clinical stage, specialty-focused bio-pharmaceutical company focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases and anemias. Our purpose is simple, to empower people with the freedom to live healthier and more fulfilling lives, by unlocking new possibilities in life sciences and providing quality healthcare solutions. Our lead drug candidate, Saroglitazar, is a liver-selective, dual peroxisome proliferator-activated receptor (PPAR) alpha / gamma agonist. Saroglitazar is an investigational treatment which has received Fast Track designation and orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of patients with primary biliary cholangitis (PBC). Saroglitazar is also an investigational treatment in development for the treatment of non-alcoholic steatohepatitis (NASH). Our second drug candidate is Desidustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF- PH) inhibitor, an investigational treatment in development for the treatment of chemotherapy-induced anemia (CIA). As a wholly-owned subsidiary of Zydus Lifesciences, our pipeline is fueled by 1,300 researchers who are working with cutting-edge technologies to discover new medicines for tomorrow.

Requirements

• Experience collaborating and interacting with internal and external partners from a variety of cultural backgrounds and geographic locations.
• Proficient with Windows Office (Word, Excel, and PowerPoint) and Adobe Acrobat.
• Must be well-organized.
• Must have excellent verbal and written skills.
• Fluent in English.
• Some measure of flexibility will be necessary.
• The ideal candidate must be able to work independently but consistently.
• Personal interactions are critical to the role. Must have good relationship skills.

Nice To Haves

• Familiarity with other languages will be noted.

Responsibilities

• Trial Master File maintenance, auditing, and reconciliation experience.
• Serve as the primary responsible party for the management of a Trial Master File (TMF).
• Archival of paper files and, if possible, experience auditing archived files.
• Meeting agenda and minute-taking experience.
• Review and manage Electronic and safety data management systems.
• Partner with others to work on international clinical trials.
• Interact with institutional review boards (IRB).
• SOP development.
• Calendar management.
• Expense report completion.
• An understanding of the regulatory requirements in the United States, as they pertain to essential documents and SOPs.
• Interacting with investigational sites.

Benefits

• Equal employment opportunities to all employees and applicants for employment.
• Prohibits discrimination and harassment of any type.
• Commitment to providing reasonable accommodation to individuals with disabilities and disabled veterans.

What This Job Offers

• Education Level: Associate degree
• Number of Employees: 11-50 employees