Senior Specialist, Submission Management, Clinical Trials

at  BristolMyers Squibb

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.
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The Submission Manager, Clinical Trials manages and coordinates the timely, compliant, and accurate delivery of the core submission documents and dossiers to BMS HA/EC Applicants and CRO. The Submission Manager also participates in the preparation of the CTIS for CT under the EU Regulation.

Position Responsibilities

• 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 considering the EU Regulation and determine windows of opportunity for submissions, escalate within BMS if needed
• Provide support to the Submission Senior Manager/collaborate with the Submission.
• Specialist 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 Program/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.
• 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.
• Provide training/mentoring to the GSM-CT newcomers.

Experience Requirements

• BA/BS degree, science / technology field preferred
• Demonstrated relevant regulatory submissions experience
• Expert knowledge of Regulatory Submissions and package content for non-US clinical trial applications to health authorities.
• Assists in the development of short- and long-term goals for own workgroup in alignment with those of GSM and the R&D umbrella.
• Resolves problems/difficulties with the assistance of Sr. team members.
• Supports other functions as appropriate.
• Independently facilitate compound/study team meetings.
• Works Independently and collaborates with other functional areas.

• 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 considering the EU Regulation and determine windows of opportunity for submissions, escalate within BMS if needed
• Provide support to the Submission Senior Manager/collaborate with the Submission.
• Specialist 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 Program/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.
• 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.
• Provide training/mentoring to the GSM-CT newcomers