Submission Document Manager - Global Drug Development

GDO Submission Document Manager

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: careers.bms.com/working-with-us.

·     Partners with the Submissions Document Manager with preparing and performing a quality check on Clinical submission deliverables.

·     Drives the development and finalization of GDO protocol-related submission deliverables to ensure requirements and targets are met according to timelines and quality expectations across assigned studies.

·     Serves as the subject matter expert on operational submission deliverables for the Study Report and/or Program.

·     Contributes toward standardization and efficiencies for the GDO protocol-related submission deliverables.

·     Partners with the Clinical Trial Support Specialists (CTSS) for the timing and creation of the submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents, providing coordination and oversight of deliverables.

·     Ensures documents received from CTSS are formatted appropriately and SRC compliant.

·     Identifies issues and addresses responses to issues; proactively manages risks within scope, driving resolution of operational issues and escalating complex or program-level risks.

·     Proactively analyzes and drives efficient problem solving within team's control.

·     Applies critical thinking, developing mitigation and resolution strategies, and promptly responding to action items.

·     Demonstrates thorough knowledge of relevant BMS SOPs and policies and provides guidance in their application to Protocol and/or Program teams.

·     Demonstrates strong project management skills, including planning, prioritization, and coordination across deliverables.

·     Demonstrates thorough knowledge of document creation and document management systems.

·     Demonstrates understanding of the pharmaceutical industry and global drug development process.

·     Manages interactions with senior level multifunctional teams across the  portfolio, to drive the operations submission documents and align delivery expectations.

·     Makes operational decisions related to execution, prioritization, and issue resolution within assigned scope, while escalating strategic or program-level decisions to senior leadership.

·     Provides guidance and mentorship to less experienced team members to support consistency and quality of deliverables.

 

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.

Supporting People with Disabilities

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

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Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1602991 : GDO Submission Document Manager

Experience Level

Mid Level