About this role
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.
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.
Travel Required
No
Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment
N/A
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 [email protected]. 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
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
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 [email protected]. 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.
R1596335 : CT Submission SpecialistOther facts
About Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science. That work inspires some of the most interesting, meaningful, and life-changing careers you’ll experience. Join us and pursue innovative ideas alongside some of the brightest minds in biopharma, collaborating with a team rich in diversity of experiences, and perspectives. We have built a sustainable pipeline of potential therapies and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient, at the right time, to achieve the best outcome.
Whether in a scientific, business or supporting function, a career at BMS means you’ll be inspired every day to grow and thrive through opportunities that are uncommon in scale and scope. Here, you’ll be on the cutting edge of powerful innovation in oncology, hematology, immunology, cardiovascular disease, and fibrosis, with colleagues united in the mission to help patients.
Through the Bristol Myers Squibb Foundation, we also promote health equity and seek to improve health outcomes of populations disproportionately affected by serious diseases and conditions. Our mission is to give new hope to help patients prevail over serious disease – it drives everything we do.
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What you'll do
- Support the creation and coordination of operational deliverables for FDA submissions. Ensure that clinical submission deliverables meet quality expectations and timelines.
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