Snr Specialist, Global Submission Management, Clinical Trials

Bristol-Myers Squibb; Uxbridge; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A leading pharmaceutical company in Uxbridge is seeking a Senior Specialist in Global Submission Management. This role is pivotal in delivering compliant Health Authority submissions that support innovative therapies. The ideal candidate will possess a BA/BS degree in a science or technology field and at least 2 years of regulatory submission experience. Responsibilities include managing core submission documents, liaising with various teams, and contributing to the clinical trials process. The position supports hybrid work arrangements.

Benefits

Competitive benefits

Career growth opportunities

Flexible work environment

Qualifications

• 2+ years relevant regulatory submission experience.
• Proficient knowledge of Regulatory Submissions for clinical trial applications.

Responsibilities

• Prepare and distribute global Clinical Trial Application dossiers.
• Manage CT Amendment log for EU Regulation.
• Liaise with teams to ensure compliance with study timelines.

Education

BA/BS degree, science / technology field preferred

Job description

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.

Shape the Future of Global Submissions!

Join a world-leading pharmaceutical company as a Senior Specialist, Global Submission Management, where you’ll play a critical role in delivering timely, compliant, and accurate Health Authority submissions that support our innovative portfolio.

In this dynamic position, you’ll manage core submission documents and dossiers for HA/EC applicants and CRO partners, ensuring excellence at every stage. You’ll also contribute to the preparation of CTIS for clinical trials under EU regulations, driving processes that enable breakthrough medicines to reach patients faster.

If you’re detail-oriented, collaborative, and passionate about regulatory excellence, this is your opportunity to make an impact on a global scale.

Key Resposnibilities

• 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.
• Manage the CT Amendment log in light of the EU Regulation and determine windows of opportunity for submissions, raise within BMS if needed
• Provide support to the Submission Manager in CTA preparation activities for initial filings and start up activities, protocol amendments, end of trials and CSR distributions.
• Ensure consistency of the Clinical Trial application across projects, studies and countries.
• Lead Study level CTA Tracking Meetings, 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
• Utilize 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
• Support GSM-CT in creation of End of Trial and tracking, as well as distribution of CSRs to Country Applicants.
• 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
• Ensure timely support for Investigator Sponsor Research Trials (ISRs) at EU level. Create cross Reference Letters and when not possible coordinate submission of CMC documentation with local Regulatory.
• Provide training/mentoring to the GSM-CT newcomers.

Degree Requirements

• BA/BS degree, science / technology field preferred

Required Experience

• 2+ years relevant regulatory submission experience

Required Competencies

• Proficient knowledge of Regulatory Submissions and package content for non-US clinical trial applications to health authorities.
• Assists in the implementation of short- and long-term goals within own work group within GSM.
• Come prepared with a solution to questions and issues as they arise.
• Supports other functions as appropriate.
• Independently facilitate study team meetings.
• Works with minimal supervision.

#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 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 [e-mail]. Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

Bristol Myers Squibb is Disability Confident – Employer

A UK Government scheme

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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.