Senior Manager, Global Submission Management, Clinical Trials
6 days ago
Bristol Myers Squibb is a leading pharmaceutical company that is committed to transforming the lives of patients through innovative solutions. We are seeking a highly skilled Senior Manager, Submission Management Clinical Trials to join our team.
Key Responsibilities- Manage and coordinate the timely, compliant, and accurate delivery of core submission documents and dossiers to BMS HA/EC Applicants and CRO.
- Participate in the preparation of the CTIS for CT under the EU Regulation.
- Lead Program/Study level CTA Tracking Meetings, ensuring timelines and dossier quality are managed according to expectations.
- Liaise with country offices and central team 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 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.
- BA/BS degree, science/technology field preferred.
- 6+ years relevant regulatory submissions experience.
- 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.
Bristol Myers Squibb is a global pharmaceutical company that is committed to transforming the lives of patients through innovative solutions. We are a leading player in the pharmaceutical industry, with a strong presence in the global market. Our company is dedicated to delivering high-quality products and services that meet the needs of our customers and patients.
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Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Lives through Innovative SolutionsBristol Myers Squibb is a leader in the pharmaceutical industry, and we're seeking a talented Senior Manager, Global Submission Management, Clinical Trials to join our team. As a key member of our submission management team, you will play a critical role in ensuring the timely, compliant, and accurate delivery...
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