Senior Specialist, Submission Management
Bristol Myers Squibb
This listing was originally posted on Bristol Myers Squibb's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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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.
Position Summary
Management Clinical Trials supports end-to-end regulatory activities for assigned projects, including executing the preparation and compilation of compliant clinical trial maintenance submissions for global health authorities.
Position Responsibilities
Collaborate with stakeholders to define clinical trial submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines.
Assess core submission deliverables to ensure compliance, prepare and distribute global CTA dossiers, and manage data required for EU CTIS and substantial modifications.
Monitor and influence the regulatory assessment process, drive negotiations with stakeholders to resolve information requests, and communicate regulatory changes to ensure ongoing compliance.
Manage and track queries, commitments, and submissions with health authorities, collaborate with subject matter experts for responses, and provide periodic status updates on commitments.
Prepare and distribute the global Clinical Trial Application dossier to country applicants and CROs for submission to ECs and HAs.
Prepare the data required in CTIS for CTA dossiers and their subsequent substantial modifications.
Execute required activities in RIM systems (Veeva RIM) and use availabile tools to generate reports and track submission content.
Continuous Improvement Initiatives
Support initiatives that promote innovation and simplify processes to enhance efficiencies for BMS teams.
Contribute to the ongoing maintenance of regulatory requirements to ensure accurate and current regulatory information.
Ensure consistency of Clinical Trial Applications across projects, studies, and countries, aligning with regulatory standards and best practices.
Requirements
Required degrees, certifications, and/or licensure relevant to role. BA/BS degree, science / technology field preferred
Minimum number of years of relevant experience expected. 1+ years relevant regulatory submission experience
Foundational knowledge of global regulatory practices, submission guidelines, and requirements
Critical thinking and problem-solving skills; proposes alternative solutions for submission-related and project situations
Effective stakeholder engagement and communication, including proficiency in English (written and oral) and ability to communicate with non-English speakers
Ability to execute and prioritize non-complex projects with attention to detail; communicates project status and updates to relevant stakeholders
Demonstrates basic presentation skills and adapts content for diverse audiences
Proficiency with desktop software and regulatory systems with the ability to instruct others; understand how non-regulatory systems interact with regulatory systems. Embrace the use of artificial intelligence and automation tools.
Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned.
Why Join Us?
Be a key leader in global studies impacting diverse therapeutic areas.
Work with talented teams across the US, India, Switzerland, and beyond.
Grow your career in a supportive, forward-thinking environment.
Make your mark in delivering high-quality, innovative clinical solutions.
Ready to take your leadership to the next level? Apply now and help us shape the next generation of Submissions Specialists.
Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.
We kindly ask all applicants to send their CV in English.
#LI-Hybrid
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.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.
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 adastaffingsupport@bms.com. 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 TAEnablement@bms.com. 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.
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