Ct Submission Specialist

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 Job Title GDO Submission Document Specialist Division Research Development Functional Area Description Global Development Operations Trial Delivery Support TDS Trial Risk and Integrity Management TRIM CT Transparency Submission Position Summary Objective Support the creation and coordination of the operational deliverables for FDA submissions Position Responsibilities Supports the GDO Submissions Document team with preparing and performing a quality check on Clinical submission deliverables Supports the development and finalization of GDO protocol-related submission deliverables ensuring requirements and targets are met according to timelines and quality expectations 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 Ensures documents are formatted appropriately and Submission Ready Compliant SRC Identifies issues and addresses responses to issues Escalates issues regarding document risks to appropriate stakeholders and or functional management to expedite resolution Applies critical thinking developing mitigation and resolution strategies and promptly responding to action items Other duties assigned to support Clinical Trials Degree Requirements Minimum of a bachelor s degree in Life science Business Administration or equivalent experience BS BA Degree with approximately 3-4 years of pharmaceutical or biotech experience in a clinical drug development setting of which at least 1-2 years should be in the pharmaceutical biotech or CRO environment Advance degree a plus Experience Requirements 1-2 years of relevant experience in clinical trial documentation management or a Clinically related or relevant field 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 Demonstrates thorough knowledge of creation of documents and the document management systems and requirements e g Core Template Key Competency Requirements Strong project management skills 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 Ability to be flexible to meet job demands manage multiple priorities and take on new initiatives and improvement efforts Demonstrated ability to work independently and seek out support when needed Strong understanding of protocol-related documents and document management systems e g CORE template Exceptional written and oral communication skills 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 TM 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 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 Visit 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 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 Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations