Snr Specialist, Global Submission Management, Clinical Trials in Uxbridge

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 will get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Bristol Myers Squibb recognises the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programmes that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Join a world-leading pharmaceutical company as a Senior Specialist, Global Submission Management, where you will play a critical role in delivering timely, compliant, and accurate Health Authority submissions that support our innovative portfolio. In this dynamic position, you will manage core submission documents and dossiers for HA/EC applicants and CRO partners, ensuring excellence at every stage. You will also contribute to the preparation of CTIS for clinical trials under EU regulations, driving processes that enable breakthrough medicines to reach patients faster.

• 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, escalating 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.
• Utilise technology effectively to support the clinical trial application submission process.
• Proficient use of CTMS, Tracking systems, Excel trackers, to generate reports and track the CTA 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.

BA/BS degree, science / technology field preferred.

2+ years relevant regulatory submission experience.

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 facilitates study team meetings. Works with minimal supervision.