Job Description:
•Provides publishing support for regulatory submissions within the life sciences industry. Includes document level and submission level publishing, archive activities, report publishing, general PDF navigation, conversion of paper documents to electronic format, and paper submissions.
• Familiarity with FDA and ICH guidelines, Life Sciences & Pharmaceutical industry
• Good knowledge on FDA, GCPs, ICH guidelines, Life Sciences and Pharmaceutical Industry.
• Familiarity of health authority procedures / guidance regarding electronic submissions
• Supports electronic communication and submission processes including general correspondence, reports and amendments. Provides quality and timely deliverables to meet the client’s expectations.
• Supports end-to-end publishing services which may include lifecycle management. Works independently with minimal supervision on common publishing tasks.
• Develops understanding and maintains knowledge of appropriate standard operating procedures (SOPs), regulations, and policies. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
• Provides regularly scheduled status on project metrics including hours spent, publishing efforts, etc. to the necessary project stakeholders both internally and externally.
• Builds knowledge of company and client regulatory publishing process, updates to regulatory authority guidelines, and software updates to ensure currency and compliance.
• Experience with various document types (CSR, CMC, Nonclinical, CRF) and applications (IND, NDA, ANDA)
• Some global application experience (US, EU, etc.)
• Minimal supervision required for common publishing tasks
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