Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren\xe2\x80\x99t 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\xe2\x80\x99ll 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: .BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.Functional Area DescriptionRegulatory Information and Submission Management is an organization that delivers Health Authority submissions and product data to support the BMS portfolio and sets the strategic business direction and related processes oversight for GRS systems.Position Summary / ObjectiveThe Submission Specialist manages and coordinates the signing of CTA documentation for all clinical trials/participates in the timely, compliant, and accurate delivery of the core submission documents and dossiers to BMS HA/EC Applicants or CRO. The Submission Specialist also participates in the preparation of the CTIS for CT under the EU Regulation.Position Responsibilities

• Manage the signing of clinical trial documentation such as powers of attorney, expected to be able to coordinate many signing at the same time.
• Provide support to the Submission Senior Specialist/Manager in CTA preparation activities for initial filings and start up activities, protocol amendments, end of trials and CSR distributions.
• Prepare and distribute the global Clinical Trial Application dossier and subsequent substantial amendments to country applicants and CROs for submission to ECs and HAs.
• Prepare the data required in CTIS for global Clinical Trial Application dossiers and their subsequent substantial modifications.
• Ensure consistency of the Clinical Trial application across projects, studies and countries.
• Actively participate in Program/Study level CTA Tracking Meetings, led by Senior Specialist/manager role, in preparation of the CTA dossier, ensuring timelines and dossier quality are managed according to expectations.
• Liaise with country offices and central team (Clinical Supply Operations, Operation Leads, Protocol Managers, Medical Monitor, Safety, Quality Person) to ensure that Clinical trial application activities are in compliance with study timelines, BMS SOPs, worldwide regulatory guidelines and regulations.
• Comply with the use and maintenance of the available planning & tracking tools (e.g. Veeva - HA submission and approval Tracking system) to generate reports and track the CTA content and associated dates.
• Escalate to study teams and GSM-CT senior roles observed trends and issues that may impact timely and successful study approval and execution
• Contribute to the Global Country Requirements Repository by collecting and sharing additional country requirements.
• Support initiatives for innovation and simplification in the processes to improve the support to the study teams and GSM-CT.
• Expected to be able to coordinate updates within a Program.
• Support continuous improvement and compliance initiatives
• Utilizes technology effectively to support the clinical trial application submission process. Proficient use of CTMS, Tracking systems, Excel trackers, to generate reports and track the CTAp content and associated dates
• Contributes to other requirements as appropriate to allow proper functioning of the GSM-CT.
• Support implementation of the EU CT REG Portal from Feb 2022

Degree RequirementsBA/BS degree, science / technology field preferredExperience Requirements1-2 years pharmaceutical experienceKey Competency Requirements

• Proficient knowledge of Regulatory Submissions and package content for non-US clinical trial applications to health authorities.
• Communicates questions and issues as they arise with possible solution.
• Supports other functions as appropriate.
• Participates in study team meetings.
• Works with supervision.

#HYDDD
#LI-HybridIf you come across a role that intrigues you but doesn\xe2\x80\x99t 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 \xe2\x80\x9cTransforming patients\xe2\x80\x99 lives through science\xe2\x84\xa2 \xe2\x80\x9d, 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 ProtocolBMS 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 . 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.

Bristol-Myers Squibb