Bristol Myers Squibb
GDOSubmissionDocumentManager
Neural analysis suggests this role is
optimal for Mid+ candidates.
“GDO Submission Document Manager at Bristol Myers Squibb. Skills: Submission document management, Clinical trial support, Process standardization. Partner with Submissions Document Manager. Perform quality check on Clinical submission deliverables”
What You'll Achieve.
Ensure requirements and targets are met; Ensure quality expectations are met
Industry & Context.
Problem solving; Issue resolution; Risk management
What They're Looking For.
Must Have
Subject matter expert on operational submission deliverables, Thorough knowledge of relevant BMS SOPs and policies, Thorough knowledge of document creation and document management systems, Understanding of the pharmaceutical industry, Understanding of global drug development process
What You'll Do.
Partner with Submissions Document Manager
Perform quality check on Clinical submission deliverables
Drive development and finalization of GDO protocol-related submission
Ensure requirements and targets are met
Serve as subject matter expert on operational submission
Contribute toward standardization and efficiencies
Partner with Clinical Trial Support Specialists for timing
Provide coordination and oversight of deliverables
Ensure documents are formatted appropriately
Ensure documents are SRC compliant
Identify issues and address responses
Proactively manage risks within scope
Drive resolution of operational issues
Escalate complex or program-level risks
Proactively analyze and drive efficient problem solving
Apply critical thinking
Develop mitigation and resolution strategies
Respond promptly to action items
Provide guidance in application of SOPs and policies
Demonstrate project management skills
Manage interactions with senior level multifunctional teams
Drive operations submission documents
Align delivery expectations
Make operational decisions related to execution
Make operational decisions related to prioritization
Make operational decisions related to issue resolution
Escalate strategic or program-level decisions
Provide guidance and mentorship to team members
Support consistency and quality of deliverables
How You'll Work.
Team & Collaboration
Senior level multifunctional teams; Cross-functional teams
Process & Methodology
Planning, Prioritization, Coordination
Full Job Description
**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](https://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 i
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