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 rich in diversity. 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 /Objective

Manage a team that Reconciles and Prepare Clinical Trial Submission documents adhering to regulatory guidelines and ensuring consistency across all BMS programs

Position Responsibilities

Supervisory responsibility for Clinical Trial Support Specialists, providing support of the in house and outsourced studies  in support of CTMS activities to ensure consistency across the team.Oversee CTSS activities to ensure compliance with ICH/GCP Guidelines, regulatory requirements.Provides leadership, infrastructure, and subject matter expertise to the Study teams and CRO’s.Prioritizes book of work for CTSS team and assign resources based on priority projects. Collaborates across multiple functions supporting clinical trial processes to ensure adherence to regulatory requirements for CTMS administrative appendices and other regulatory documents.Identify efficiency opportunities to streamline process.Maintains continuous knowledge of the regulatory requirements and industry trends related to regulatory SubmissionsCommunicate as appropriate with relevant stakeholders Leads and participates in continuous improvement initiatives related to clinical trial documentation.Must be competent in Project Management tools and methodologies.Excellent organizational and time management skillsTechnical expert and able to further develop KPIs and metrics.Strong analytical, problem-solving, and critical thinking skillsMust be able to interact and communicate effectively at all levels of the organizationDemonstrates 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.Performs other tasks as assigned.

Degree Requirements

Minimum of a Bachelor’s degree in a scientific or related discipline, advanced degree preferred

Experience Requirements

At least 5-7 years of experience in health sciences or related industry Supervisory responsibility, provides training, support, and coaching as require.Strong working knowledge of Clinical Trial Managements Systems preferably Veeva Vault. Strong organizational and technical ability.Demonstrated Excel, PowerPoint, and SharePoint skills.   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.

Key Competency Requirements

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. 

#HYDDD #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.

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 an inclusive culture, promoting diversity 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 a diverse 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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: https://careers.bms.com/california-residents/

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