| Tech Support --Princeton, NJ at Princeton, New Jersey, USA |
| Email: harsh.kashyap@tekinspirations.com |
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From: Harsh Kumar Kashyap, TEK Inspirations LLC harsh.kashyap@tekinspirations.com Reply to: harsh.kashyap@tekinspirations.com Job Description - Title: Tech Support ( Bio Pharma/Lorenz DocuBridge ) Location: Princeton, NJ (Hybrid) Duration: 6 Months Candidate must be technical in IT and have the tools and business experience specified in the JD. looking for the highly skilled and experienced Senior IT Support Engineer/Consultant with specialized expertise in Regulatory affairs dossier publishing within the bio-pharma regulatory environment. The ideal candidate will provide advanced technical support, maintenance, and troubleshooting for the regulatory systems, ensuring seamless dossier publishing processes and compliance with industry standards. Key Responsibilities : Provide advanced technical support for bio-pharma regulatory systems, focusing on dossier publishing. Troubleshoot and resolve complex issues related to dossier publishing, ensuring timely and accurate submissions. Collaborate with the Dev team, regulatory affairs/operations, quality assurance, and other departments to understand and address their IT needs. Act as a liaison between IT and business units to ensure alignment and effective communication. Maintain and update regulatory systems to comply with industry standards and regulatory requirements. Conduct regular system audits and generate comprehensive reports to ensure data integrity and compliance. Assist in the development and implementation of new features and enhancements for regulatory systems. Lead projects to support and mature these platforms, rolling them out to various users and countries. Document knowledge articles, training materials, and provide support to end-users on regulatory systems and dossier publishing processes. Document and maintain standard operating procedures (SOPs) and best practices for regulatory systems support. Conduct regular system audits and generate detailed reports to ensure data integrity and compliance. Analyze audit results and implement corrective actions as needed. Stay updated with the latest industry trends and regulatory requirements related to dossier publishing. Continuously seek opportunities to improve system performance and user experience. Qualifications : Bachelor s degree in information technology, Computer Science, or a related field. Minimum 5 years of experience in IT support, with a focus on bio-pharma regulatory systems and dossier publishing. Experience with electronic document management systems (EDMS) and regulatory information management systems (RIMS). Technical Proficiency in regulatory software and tools used for dossier publishing (e.g., Lorenz DocuBridge, Extedo Liquent, Veeva Vault etc.). Expertise in supporting and maturing these platforms and rolling them out to various users and countries. Experience in configuring and troubleshooting various dossier system integrations using connectors such as Generis CARA and Veeva. Strong understanding of regulatory requirements and industry standards for dossier publishing. Technical proficiency in regulatory software and tools used for dossier publishing. Good understanding of Software Development Life Cycle (SDLC) processes. Excellent problem-solving skills and the ability to troubleshoot complex technical issues. Strong communication and interpersonal skills, with the ability to work effectively with cross-functional teams. Detail-oriented with a strong focus on accuracy and compliance. Ability to manage multiple tasks and prioritize effectively in a fast-paced environment. Keywords: information technology New Jersey Tech Support --Princeton, NJ harsh.kashyap@tekinspirations.com https://jobs.nvoids.com/job_details.jsp?id=1839926 |
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| 11:12 PM 14-Oct-24 |