CT Submission Specialist

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