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 rich in diversity. 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
Position Purpose
The Senior Specialist manages and coordinates the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities.
Key Responsibilities
· Tracks, collects, and reviews all components for submission to health authorities.
· Engages with responsible parties to ensure high-quality submission documents.
· Facilitates submission team meetings with appropriate team support.
· Participates in focused projects related to their scope of work.
· Prepares cover letters, FDA forms, and submission content plans for investigational and marketed application submissions, including CSRs, variations, DSURs, PSURs, and initial IND submissions.
· Attends submission team and kick-off meetings, represents RISM, and drives submission publishing timelines.
· Coordinates initial IND kick-off meetings and submissions for IND, NDA, BLA, and orphan drug annual reports.
· Develops and updates job aid documents for departmental processes.
· Builds and manages CARA/PRISM structures for global CMC submissions (CMC Submission Specialist).
· Coordinates non-eCTD submissions with the International Regulatory Team Lead.
Qualifications and Experience
· BA/BS degree in a science or technology-related field preferred.
· Relevant submissions experience.
Key Competencies
· Foundational knowledge of global regulatory practices, submission guidelines, and requirements.
· Assists in the implementation of short- and long-term goals within their workgroup in RISM.
· Proactive problem-solving: Comes prepared with solutions to questions and issues as they arise.
· Engages relevant stakeholders to help address challenges.
· Strong English proficiency (written and oral) with the ability to communicate effectively with non-English speakers.
· Basic presentation skills to deliver content to diverse audiences.
· Project execution skills: Ability to prioritize tasks with strong attention to detail.
· Communicates project status and updates to relevant stakeholders as needed.
· Applies critical thinking skills to daily workload decisions in alignment with group/company objectives.
· Proposes alternative solutions for submission-related and project-specific situations.
· Understands stakeholder needs, priorities, and working processes.
· Proficiency in desktop application software suites.
· Experience with computer systems in an R&D environment.
#LI-Hybrid
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 an inclusive culture, promoting diversity 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 a diverse 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 [email protected]. Visit careers.bms.com/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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Bristol Myers Squibb is Disability Confident – Employer
A UK Government scheme
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