Bristol Myers Squibb (BMS), a global biopharmaceutical leader known for transforming patients’ lives through science, is hiring a CT Submission Specialist (GDO Submission Document Specialist) in Hyderabad, Telangana. This full-time role within Global Development Operations (GDO) supports FDA clinical trial submissions, offering an excellent opportunity for professionals experienced in clinical trial documentation, regulatory submissions, and ICH-GCP compliance to grow their careers in a world-class R&D environment.
If you have hands-on experience with clinical submission documents, CTMS/eTMF systems, and cross-functional trial support, this role aligns strongly with long-term career growth in clinical research operations and regulatory submissions.
Job Details
- Job Title: CT Submission Specialist / GDO Submission Document Specialist
- Company: Bristol Myers Squibb
- Location: Hyderabad, Telangana, India
- Job Type: Full-time
- Department: Research & Development – Global Development Operations
- Job Requisition ID: R1596335
- Work Model: Site-by-Design (Hybrid – minimum 50% onsite)
Key Responsibilities
As a CT Submission Specialist at BMS, you will:
- Prepare, format, and quality-check clinical trial submission deliverables for FDA submissions
- Support protocol-related submission documents, ensuring compliance with timelines and quality standards
- Coordinate with Clinical Trial Support Specialists (CTSS) for CSR appendices, financial disclosure tables, and related documents
- Ensure all documents are Submission Ready Compliant (SRC)
- Identify documentation risks, resolve issues, and escalate when required
- Apply critical thinking to develop mitigation strategies for submission challenges
- Support additional clinical trial documentation activities as assigned
Qualifications & Experience
Education
- Bachelor’s degree in Life Sciences, Pharmacy, Business Administration, or equivalent
- Advanced degree preferred
Experience
- 3–4 years of experience in pharmaceutical, biotech, or CRO environments
- 1–2 years of hands-on experience in clinical trial documentation or submission management
- Strong understanding of ICH-GCP, FDA regulations, and drug development processes
Technical Skills
- Experience with eTMF / CTMS systems
- Veeva Vault Clinical experience preferred
- Proficiency in MS Office, SharePoint, and clinical trial systems
- Knowledge of CORE templates and submission documentation standards
Key Skills & Competencies
- Strong project and time-management skills
- Ability to work in cross-functional, global matrix teams
- Excellent written and verbal communication skills
- High attention to detail and quality compliance
- Ability to manage multiple priorities independently
Salary & Benefits
- Estimated Salary Range: ₹8,00,000 – ₹14,00,000 per annum (INR)
- Competitive compensation aligned with industry standards
- Comprehensive health and wellness benefits
- Career development and global learning opportunities
- Inclusive, employee-centric work culture
How to Apply
