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Bristol Myers Squibb
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Senior Specialist, CMC Submission Management

Senior Specialist, CMC Submission Management

Bristol Myers Squibb

5 - 10 years

7 - 12 Lacs

hyderabad

Posted:1 month ago| Platform:

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Skills Required

adobe acrobat publishing excel clinical trials cmc manager technology nda data privacy ms office recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us .

Responsibilities:

Tracks, collects, and reviews all components for submission to Health Authorities.
Perform submission publishing activities
Interacts with responsible parties for quality submission documents for submissions.
Facilitate submission team meetings with team support.
May participate in focused projects related to their scope of work.
Prepare Cover Letter, FDA Forms and submission content plan for Investigational, Marketed Applications submissions (CSR, Variations, DSURs, PSURs, Initial IND Submission).
Attend Submission Team and kick off meetings, represent RISM and drive submission publishing timelines.
Coordinate Initial IND Kick off meeting submission.
Coordinate IND, NDA, BLA and Orphan Drug Annual Reports.
Develop/Update job aid documents for departmental process.
Build/Manage CARA/PRISM Structures for Global CMC Submissions (CMC Submission Specialist).
Coordinate non-eCTD submissions with International Regulatory Team lead.

Requirements :

5+ years relevant submissions experience
Foundational knowledge of global regulatory practices, submission guidelines and requirements.
Assists in the implementation of short- and long-term goals within own work group within RISM.
Come prepared with a solution to questions and issues as they arise.
Engages relevant stakeholders to help address the problem.
Proficient in the English language 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 the ability to prioritize tasks with strong attention to detail.
Communicates project status and updates, as appropriate, to relevant stakeholders.
Applies critical thinking skills to daily workload decisions, in alignment with group/company objectives.
Proposes alternative solutions for submission-related and/or project situations.
Seeks to understand stakeholder needs, priorities, working processes, and activities.
Understands and embraces the use of specific regulatory systems and associated tools based on area of expertise or job function.
Has intermediate-level working knowledge of common desktop software (eg, Microsoft Office Suite, Adobe Acrobat, and SharePoint).

Educational Qualifications:

BA/BS degree, science / technology field preferred.

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Senior Specialist, CMC Submission Management