Senior Manager, Global Submission Management, Clinical Trials

6 months ago

Hyderabad, India Bristol Myers Squibb Full time

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.

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.

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.

Position Summary
The Senior Manager, Submission Management 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 Senior Submission Manager also participates in the preparation of the CTIS for CT under the EU Regulation. 
 

Position Responsibilities
• Manages a team of direct reports within the team supporting clinical trial applications.
• Prepare and distribute the global Clinical Trial Application dossier 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. 
• 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 SM-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 SM-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 SM-CT.
• Support implementation of the EU CT REG Portal from Feb 2022. 
• Provide training/mentoring to the SM-CT newcomers/managers.


Degree Requirements
BA/BS degree, science / technology field preferred


Experience Requirements
6+ years relevant regulatory submissions experience


Key Competency Requirements
• Expert knowledge of Regulatory Submissions and package content for non-US clinical trial applications to health authorities.
• Anticipates and resolves problems/difficulties at the cross-functional level with minimal assistance.
• Supports other functions as appropriate.
• Independently facilitate compound/study team meetings.
• Works Independently and collaborates as a SM representative with other functional areas.
 

#HYDDD

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