Senior Specialist, CMC Submission Management

Working with Us

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: .

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.

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.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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