CT Submission Specialist (GDO Submission Document Specialist)
Location: Hyderabad, Telangana, India
Category: Clinical Research / Regulatory Submissions
Company: Bristol Myers Squibb (BMS)
About the Role
Bristol Myers Squibb is seeking a CT Submission Specialist to support global clinical trial documentation, regulatory submissions, and submission-ready deliverables within the Global Development Operations (GDO) division. This role contributes directly to the successful delivery of clinical trial submissions to global health authorities, including the FDA.
The position sits within Trial Delivery Support (TDS), Trial Risk and Integrity Management (TRIM), and CT Transparency & Submission functions.
Key Responsibilities
Support creation, coordination, and quality review of clinical submission documents.
Prepare, format, and finalize protocol-related submission deliverables ensuring submission-ready compliance (SRC).
Collaborate closely with Clinical Trial Support Specialists (CTSS) to deliver documents such as CSR appendices and Financial Disclosure Tables.
Identify document-related risks and escalate issues to stakeholders for quick resolution.
Apply critical thinking to manage issues, propose mitigation strategies, and follow up on action items.
Maintain compliance with document management systems, templates, and format standards.
Perform additional tasks required to support global clinical trials.
Education Requirements
Bachelor’s degree in Life Sciences, Biotechnology, Pharmacy, Business Administration, or related field.
Advanced degree (MS/MPH/MBA) is an added advantage.
Experience Requirements
1–2 years of relevant experience in clinical trial documentation, regulatory submissions, or clinical research operations.
3–4 years total industry experience in pharmaceutical, biotech, or CRO environments preferred.
Strong knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
Experience working with:
Clinical Trial Master File (TMF) systems
Veeva Vault Clinical (preferred)
CTMS systems
MS Office Suite, SharePoint, and clinical portals/databases
Proven understanding of document creation and document management systems (Core Templates, SRC compliance).
Key Competencies
Strong project management and organizational skills.
Ability to manage multiple priorities and work in fast-paced environments.
Experience collaborating within cross-functional, multicultural teams.
Ability to work independently with minimal supervision.
Excellent written and verbal communication skills.
Strong understanding of protocol-related documents and document workflows.
Why Join Bristol Myers Squibb?
At BMS, employees contribute to work that directly impacts global patient outcomes. The company fosters a culture of innovation, accountability, inclusion, and integrity, offering growth opportunities within the global drug development and regulatory ecosystem.
Work Environment
BMS follows a structured onsite/hybrid/remote work model based on job requirements:
Site-essential: Full onsite presence
Site-by-design: Hybrid model with at least 50% onsite
Remote-by-design/Field roles: Flexibility with essential travel requirements
Equal Opportunity Employment
BMS is committed to diversity and inclusion and provides reasonable accommodations for applicants with disabilities. All employment decisions follow applicable equal employment opportunity laws.
How to Apply
Candidates who meet most of the requirements are encouraged to apply. You may be closer to a transformative career opportunity than you think.
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