IM Regulatory Validation Lead

Senior Technical Lead Job Title: IM Regulatory Validation Lead Location: Raritan, NJ (Hybrid) W2/C2C Job Details: Technical Lead is responsible for end-to-end technical ownership of a Unified Regulatory Platform (URP) built on Veeva and AWS based cloud stack 1. Work with cross functional team 2. Ensure all deliverables are met 3. Ensure Timeline is met, 2. Act as technical single point of contact for large regulatory programs 3. Understanding of Veeva (highly preferred) and AWS stack is a must.

Job Details: Technical Lead is responsible for end-to-end technical ownership of aUnified Regulatory Platform (URP) built on Veeva and AWS based cloud stack 1. Work with cross functional team 2. Ensure all deliverables are met 3. Ensure Timeline is met, 2. Act as technical single point of contact for large regulatory programs 3. Understanding of Veeva (highly preferred) and AWS stack is a must.

Role - CSV Consultant Location - Raritan, NJ(Hybrid) Job Details: Experience in the Pharmaceutical, biotechnology, or medical device industry 2+ years experience with System Development Lifecyle 3+ years experience in Computer System Validation (Based on the role selected) Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance s and industry standards (i.e., GAMP) Experience in writing and execut

Ex-J&J preferred Experience in the Pharmaceutical, biotechnology, or medical device industry 2+ years experience with System Development Lifecyle 3+ years experience in Computer System Validation (Based on the role selected) Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidances and industry standards (i.e., GAMP) Experience in writing and executing documentation for all aspects of the validation