At Bristol Myers Squibb, our employees often ask, Who are you working for—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

In conjunction with the Submission Manager, and use of technologies, simplify the end-to-end process for Clinical Trial documents, maintenance and submissions
Prepare Clinical Trial Submission documents adhering to regulatory guidelines and ensuring consistency across all BMS programs. 
Partners with the Submission Manager for the timing and creation of the submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents.
Ensures documents are formatted appropriately and Submission Ready Compliant (SRC)
In collaboration with out outsourced partners, creates site numbers for new and ongoing clinical trials.
Enters site milestones and regulatory approvals dates to maintain the quality health of the trail assigned to.
Ensures Drug shipment address are entered correctly, and feed to SAP to enable IP Supply to sites.
Performs a reconciliation of Veeva (eTMF/CTMS) to ensure accurate data is available and reflecting correctly.
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 the ability to provide timely guidance in their application to Protocol and/or Program teams. Assesses operational feasibility using GCPs, ICH and regulatory legislation and guidelines as they apply to submission deliverables where applicable.
Demonstrates strong project management skills
Demonstrates thorough knowledge of creation of documents, and the document management systems and requirements (e.g. Core Template).
Demonstrate understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.
Manages interactions with senior level multifunctional teams across the oncology portfolio, to drive the operations submission documents.
Other duties as assigned to support Clinical Trials.
Performs other tasks as assigned.

Minimum of a bachelor's degree in Life science. BS/BA Degree with approximately 4 years of pharmaceutical or biotech experience in a clinical drug development setting, of which at least 2 years should be in the pharmaceutical, biotech or CRO environment. Advance degree a plus.

Demonstrated knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma.
Experience in the use of industry Clinical Trial Master File Systems or equivalent. Experience with Veeva Vault Clinical preferred
Experience with MS office suite, SharePoint, etc. CTMS (Veeva Vault experience preferred), knowledge of portals, databases and other Clinical Trial enabling technologies.
Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.
Strong organizational, time-management, analytical and decision-making skills to efficiently evaluate, plan and accomplish work goals.
Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure.
Proven time management skills and ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts.
Ability to sustain high levels of performance in a constantly changing environment.
Demonstrates a high level of adaptability in dealing with ambiguous and complex work environment and balances multiple demands on role in a responsive and professional manner.
Ability to prioritize work and assess risk to meet the needs of the organization.
Demonstrated ability to work independently and seek out support when needed.
Proactive, adaptable and able to modify personal and organizational work style to meet the needs of the business.
Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.
Strong understanding of GCPs, ICH and regulatory regulations and guidelines as they apply to protocol management and program strategy.
Understands the influences of safety and efficacy profiles, labeling, legislation and marketing on the life cycle of a compound.
Strong understanding of protocol-related documents, and document management systems (e.g. CORE template).
Ability to manage complex issues and proactively apply critical thinking to address challenges. Some positions may require experience in a specific therapeutic area.

Exceptional written and oral communication skills. 

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https //careers.bms.com/ways-of-working.

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 [HIDDEN TEXT]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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

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R1606882 Clinical Trial Support Specialist