Manager 1, 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 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 responsibilities

• Provides advice regarding regulatory and submission requirements, dossier content, and format using in-depth knowledge of eCTD submission production
• Supports the execution of the Global Submission Plan through collaborating with team members and vendors
• Tracks progress of all components for submission to Health Authorities
• Independently facilitate submission team meetings
• Interacts with responsible parties to aid in ensuring that components are received in a timely manner and provide direction to assure quality results are produced
• Supports research for legal due diligence activities, document and Submission Management for acquisitions, partnerships and divestitures, assisting in internal audits and regulatory agency inspections
• Attend submission team and kick off meetings, represent SM, drive submission publishing timelines
• Facilitate Initial IND Kick off meeting submission
• Coordinate IND, NDA, BLA and Orphan Drug Annual Reports
• Other miscellaneous regulatory operational activities
• Develop/Update job aid documents for departmental process
• May facilitate in focused projects related to their scope of work

Experience requirements

• BA/BSc degree, science / technology field preferred
• 5+ years relevant submissions experience
• Proficient knowledge of global regulatory practices, electronic submission guidelines and requirements
• Effective influencing and collaboration skills, team player
• Effective written and verbal communication skills and presentation skills
• Ability to work Independently
• Ability to prioritize, manage multiple tasks and strong attention to detail
• Uses critical thinking to resolve submission-related situations.
• Must be comfortable working in an environment that utilizes electronic docbases, databases, publishing and computer systems (Microsoft Office, Outlook, eCTD viewers and web based applications) and be technically savvy with such systems.
• Ability to manage multiple projects simultaneously and meet ambitious timelines

#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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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 – Committed

A UK Government scheme