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Bristol Myers Squibb
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Specialist, CMC Submission Management

Specialist, CMC Submission Management

Bristol Myers Squibb

2 - 4 years

8 - 12 Lacs

hyderabad

Posted:5 days ago| Platform:

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Skills Required

regulatory submissions writing adobe acrobat sharepoint clinical trials career development desktop applications microsoft office suite

Work Mode

Work from Office

Job Type

Full Time

Job Description

Tracks, collects, and reviews all components for submission to Health Authorities.
Performs submission publishing activities and interacts with responsible parties for quality submission documents.
Facilitates submission team meetings and supports the submission process.
Prepares Cover Letter, FDA Forms, and submission content plan for Investigational, Marketed Applications submissions.
Attends Submission Team and kick off meetings, represents RISM, and drives submission publishing timelines.
Coordinates Initial IND Kick off meeting submissions and develops/updates job aid documents for departmental processes.

Job Requirements

2-4 years of relevant experience in regulatory submissions.
Foundational knowledge of global regulatory practices, submission guidelines, and requirements.
Proficient working knowledge of common desktop applications (e.g., Microsoft Office Suite, Adobe Acrobat, SharePoint).
Hands-on experience in submission publishing activities using DocuBridge, Lorenz, and other relevant software.
Demonstrates critical thinking skills to daily workload decisions, aligning with group/company objectives.
Communicates project status and updates to relevant stakeholders.
Applies intermediate-level working knowledge of common desktop software (e.g., Microsoft Office Suite, Adobe Acrobat, and SharePoint).
BA/BS degree, preferably in science or technology.

About Company

Bristlecone is a leading healthcare company committed to transforming patients' lives through innovative solutions. We offer a dynamic work environment that fosters growth and development, along with competitive benefits and programs designed to support our employees' well-being.

Additional Info

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely interesting work, life-changing careers. With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.

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Specialist, CMC Submission Management