Job Description

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• Successfully meet/ complete training milestones relevant to the position held.
• Familiarity with FDA, GCPs, ICH guidelines, Life Sciences & Pharmaceutical industry
• Familiarity of health authority procedures / guidance regarding electronic submissions
• Perform submission publishing, assembly, and distribution activities within the specified training period
• Notifying relevant stakeholders that the file is ready for approval
• Multi-skilled on all allocated submissions within the team
• Adapting and willing to multi-skill and assisting in other submission/task within the team
• A high level of independent judgment/action in problem solving
• Keeping Team Leader informed of non-routine issues, making recommendations to resolve these issues
• Self-Development and Take Responsibilities for the same
• Active involvement in projects and quality/change initiatives
• By continually upgrading domain knowledge
• Following company rules and standard operating procedures
• Adhering to all Security Policies and Procedures
• Promoting a positive and professional image of the team always
• Need to abide to the existing Information Security Policies and Procedures
• Bachelors degree in life sciences specialty (pharmaceutical /biotech) 1-2 years of Regulatory Publishing experience
• Familiarity with FDA and ICH guidelines, Life Sciences & Pharmaceutical industry
• Experience with various document types (CSR, CMC, Nonclinical, CRF) and applications (IND, NDA, ANDA)
• Familiarity of health authority procedures / guidance regarding electronic submissions.
• Some global application experience (US, EU, etc.)
• Minimal supervision required for common publishing tasks

Recruitment fraud is a scheme in which fictitious job opportunities are offered to job seekers typically through online services, such as false websites, or through unsolicited emails claiming to be from the company. These emails may request recipients to provide personal information or to make payments as part of their illegitimate recruiting process. DXC does not make offers of employment via social media networks and DXC never asks for any money or payments from applicants at any point in the recruitment process, nor ask a job seeker to purchase IT or other equipment on our behalf. More information on employment scams is available .

DXC Technology