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Bristol Myers Squibb
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Senior Specialist, Submission Management

Senior Specialist, Submission Management

Bristol Myers Squibb

3 - 6 years

6 - 11 Lacs

hyderabad

Posted:1 week ago| Platform:

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Skills Required

csr writing cmc clinical trials life sciences nda career development patient care

Work Mode

Work from Office

Job Type

Full Time

Job Description

Manage and coordinate timely, compliant, and accurate delivery of submission documents and dossiers to health authorities.
Track, collect, and review all components for submission to Health Authorities.
Interact with responsible parties for quality submission documents for submissions.
Facilitate submission team meetings and provide support.
Prepare Cover Letter, FDA Forms, and submission content plan for Investigational, Marketed Applications submissions.
Attend Submission Team and kick off meetings, represent RISM, and drive submission publishing timelines.
Coordinate Initial IND Kick off meeting submissions and manage annual reports for IND, NDA, BLA, and Orphan Drug submissions.
Develop/Update job aid documents for departmental processes and build/manage CARA/PRISM structures for Global CMC Submissions (CMC Submission Specialist).
Coordinate non-eCTD submissions with International Regulatory Team lead.

Job Requirements

3+ years of relevant submissions experience.
Foundational knowledge of global regulatory practices, submission guidelines, and requirements.
Ability to assist in implementing short- and long-term goals within own work group within RISM.
Proficient in English, both written and oral, and able to communicate effectively in written form with non-English speakers.
Demonstrates basic presentation skills needed to deliver content to a variety of audiences.
Demonstrates the ability to execute a non-complex project, including prioritizing tasks with strong attention to detail.
Communicates project status and updates, as appropriate, to relevant stakeholders.
Applies critical thinking skills to daily workload decisions, aligning with group/company objectives.
Proposes alternative solutions for submission-related and/or project situations.
Seeks to understand stakeholder needs, priorities, working processes, and activities.
Good understanding of desktop application software suites and knowledge of computer systems in an R&D environment.
A BA/BS degree is preferred, ideally in science or technology.

About Company

Bristol Myers Squibb India Pvt.LTD. offers a wide variety of competitive benefits, services, and programs that provide employees with the resources to pursue their goals, both at work and in their personal lives. We recognize the importance of balance and flexibility in our work environment.

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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Senior Specialist, Submission Management