Associate, Clinical Trials at Zydus Therapeutics Inc.

Hopewell Township, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Aug, 26

Salary

80000.0

Posted On

04 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Trial Master File management, Auditing, SOP development, Data management, Regulatory compliance, Clinical trials, Microsoft Office, Excel, Adobe Acrobat, Communication, Relationship management, Organizational skills, Meeting coordination, Expense reporting, IRB interaction

Industry

Pharmaceutical Manufacturing

Description

Description SUMMARY: 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. 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. Requirements QUALIFICATIONS – SKILLS & REQUIREMENTS: - Experience collaborating and interacting with internal and external partners from a variety of cultural backgrounds and geographic locations. (Although note require, familiarity with other languages will be noted.) - Proficient with Windows Office (Word, Excel, and PowerPoint) and Adobe Acrobat. o Excel will be used extensively. Experience with chart development and basic functions are necessary. - Must be well-organized. - Must have excellent verbal and written skills. - Fluent in English. - Some measure of flexibility will be necessary. Due to the international framework of the organization, there will be instances wherein meetings are scheduled during non-traditional workday hours. This usually occurs no more than 2 hours prior to the standard workday. - The ideal candidate must be able to work independently but consistently. - Personal interactions are critical to the role. Must have good relationship skills. EDUCATION & EXPERIENCE: - Minimum of Associate’s Degree, Bachelor’s Degree preferred. TRAVEL: - Minimal, less than 10% WORK ENVIRONMENT: This is an office-based position, located in our office in Pennington, NJ. The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual is: • Frequently required to sit and/or stand, walk, talk, and hear. • Ability to sit at a computer for an extended period of time. • Vision ability requirements include clarity of visions at 20 inches or less due to computer work. • Moderate noise (i.e., background noise due to computers, phone, printers, and light hallway traffic). • Constantly required to use hands and fingers to operate office machines and equipment. • Frequently required to reach with hands and arms. Occasionally required to stoop, kneel, and crouch. The work environment characteristics described here are representative of those that an individual encounters while performing the essential functions of this job. Zydus Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Zydus is committed to providing reasonable accommodation to, among others, individuals with disabilities and disabled veterans. If you need an accommodation because of a disability to search and apply for a career opportunity with Zydus, please contact us and let us know the nature of your request.

Responsibilities

The associate will serve as the primary party responsible for the maintenance, auditing, and reconciliation of the Trial Master File. They will also manage electronic and safety data systems while coordinating with international clinical trial partners and institutional review boards.