Submission Specialist

Bristol Myers Squibb

2 - 5 years

4 - 8 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

pharmaceutical project management presentation skills content editing teaching scope management english language excel creative writing content development stakeholder management writing content writing life sciences communication skills

Work Mode

Work from Office

Job Type

Full Time

Job Description

Tracks, collects, and reviews all components for routine submissions to Health Authorities.
Interacts with responsible parties for quality submission documents for routine submissions.
Troubleshoots issues found in components received and interacts with responsible parties for clarification or revision.
Prepares Cover Letter, FDA Forms, and submission content plan for routine submissions.
Performs submission verification on published submissions to confirm eCTD compliance.
Updates RIM system with US planned submissions and updates entries with submitted submissions.
Participates in submission team meetings as applicable and coordinates non-eCTD submissions with International Regulatory Team lead.
Engages relevant stakeholders to address problems, applies critical thinking skills to daily workload decisions, and seeks to understand stakeholder needs and priorities.

Job Requirements

BA/BS degree in science or technology field preferred.
Foundational knowledge of global regulatory practices, submission guidelines, and requirements.
Demonstrates basic presentation skills needed to deliver content to various audiences.
Ability to execute non-complex projects with strong attention to detail.
Proficient in English, both written and oral, and able to communicate effectively in written form with non-English speakers.
Good understanding of desktop application software suites and practical knowledge of computer systems in an R&D environment.

Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

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