Senior Specialist, Submission Management
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Position Overview
The Senior Specialist manages and coordinates the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities.
Key Responsibilities
1. Track, collect, and review all components for submission to health authorities.
2. Engage with responsible parties to ensure high-quality submission documents.
3. Facilitate submission team meetings with appropriate support.
4. Participate in projects related to their scope of work.
5. Prepare cover letters, FDA forms, and submission content plans for various applications.
6. Attend submission team and kick-off meetings, representing RISM, and drive timelines.
7. Coordinate initial IND meetings and submissions for various drug applications and reports.
8. Develop and update departmental process documents.
9. Manage CARA/PRISM structures for global CMC submissions.
10. Coordinate non-eCTD submissions with the International Regulatory Team Lead.
Qualifications and Experience
* BA/BS degree in a science or related field preferred.
* Relevant submissions experience.
Key Competencies
* Knowledge of global regulatory practices and submission guidelines.
* Proactive problem-solving skills.
* Effective stakeholder engagement.
* Strong English communication skills.
* Basic presentation skills.
* Project management and prioritization skills.
* Critical thinking and stakeholder understanding.
* Proficiency in desktop software and experience with R&D computer systems.
We encourage candidates who find a role intriguing even if it doesn't perfectly match their resume to apply, as it could be a transformative opportunity.
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