CT Submission Specialist Jobs in Hyderabad at Bristol Myers Squibb for clinical trial submissions regulatory documentation and FDA compliance roles.
Job Title: CT Submission Specialist (GDO Submission Document Specialist)
Job Requisition ID: R1596335
Job Location: Hyderabad, Telangana, India
Employment Type: Full-Time
Division: Research & Development
Functional Area: Global Development Operations (GDO) – CT Transparency & Submission
Work Mode: On-site / Site-by-design as per BMS occupancy structure
About the Company
Bristol Myers Squibb is a global biopharmaceutical organization driven by a single mission: transforming patients’ lives through science. The company is known for its leadership in oncology, immunology, cardiovascular disease, fibrosis, and cell therapy, delivering innovative medicines that address serious diseases with unmet medical needs. CT Submission Specialist Jobs in Hyderabad
At Bristol Myers Squibb (BMS), employees work on uniquely interesting and meaningful projects that directly impact patient lives across the globe. The organization fosters a culture of innovation, inclusion, accountability, and integrity, empowering employees to grow professionally while contributing to life-changing scientific advancements.
BMS strongly believes in work-life balance and flexibility, offering competitive benefits, learning opportunities, and a supportive work environment. With global operations and high-impact research programs, BMS provides unmatched exposure to large-scale, complex clinical development activities.
As part of its continued expansion in India, Bristol Myers Squibb is currently hiring a CT Submission Specialist for its Global Development Operations team in Hyderabad. CT Submission Specialist Jobs in Hyderabad
Job Details
- Job Title: CT Submission Specialist
- Internal Role Name: GDO Submission Document Specialist
- Department: Global Development Operations (GDO)
- Division: Research & Development
- Location: Hyderabad, Telangana, India
- Employment Type: Full-Time
- Travel Requirement: No
- Job Level: Experienced Professional
This role supports FDA and global regulatory submissions related to clinical trials and plays a critical role in ensuring submission readiness and compliance. CT Submission Specialist Jobs in Hyderabad
Job Description
The CT Submission Specialist position at Bristol Myers Squibb is a key role within the Global Development Operations function, supporting the creation, coordination, and quality control of clinical trial submission deliverables. The primary objective of this role is to ensure accurate, compliant, and timely preparation of operational documents for FDA and global health authority submissions. CT Submission Specialist Jobs in Hyderabad
The role requires close collaboration with Clinical Trial Support Specialists, cross-functional teams, and submission stakeholders to manage protocol-related submission documents such as CSR appendices, financial disclosure tables, and associated clinical trial documentation.
This position is ideal for professionals with experience in clinical documentation management, regulatory submissions, and clinical trial operations who are looking to advance their careers in a global biopharmaceutical organization. CT Submission Specialist Jobs in Hyderabad
Skills / Qualifications
Educational Qualifications
- Bachelor’s degree in Life Sciences, Business Administration, or a related discipline
- Equivalent relevant experience may be considered
- Advanced degree is an added advantage
Professional Experience
- Approximately 3–4 years of experience in pharmaceutical, biotech, or CRO environments
- Minimum 1–2 years of experience in clinical trial documentation management or a closely related clinical field
- Experience working within regulated clinical development environments
Technical Knowledge
- Strong understanding of ICH, GCP, and regulatory guidelines
- Knowledge of the clinical drug development lifecycle
- Experience using Clinical Trial Master File (CTMF) systems
- Hands-on experience with Veeva Vault Clinical preferred
- Proficiency in MS Office tools and SharePoint
- Familiarity with CTMS platforms, portals, databases, and clinical trial technologies
- Understanding of document creation standards and core templates
CT Submission Specialist Jobs in Hyderabad
Key Responsibilities
- Support the GDO Submissions Document team in preparing and performing quality checks on clinical submission deliverables
- Assist in the development and finalization of protocol-related submission documents, ensuring timelines and quality expectations are met
- Coordinate with Clinical Trial Support Specialists (CTSS) for document creation and submission scheduling
- Prepare and manage submission documents including CSR appendices, financial disclosure tables, and related clinical trial documentation
- Ensure documents are properly formatted and Submission Ready Compliant (SRC)
- Identify document-related issues, propose solutions, and escalate risks to appropriate stakeholders when required
- Apply critical thinking to develop mitigation and resolution strategies for submission challenges
- Respond promptly to action items to maintain submission timelines
- Support additional clinical trial documentation activities as assigned
- Collaborate effectively with cross-functional, multicultural teams in a matrix environment
CT Submission Specialist Jobs in Hyderabad
Key Competency Requirements
- Strong project management and organizational skills
- Excellent time management and ability to handle multiple priorities
- Analytical and decision-making capabilities
- Ability to work independently while proactively seeking guidance when required
- Strong understanding of protocol-related documents and document management systems
- High attention to detail and quality-focused mindset
- Exceptional written and verbal communication skills in English
- Flexibility to adapt to evolving project needs and improvement initiatives
Benefits / Perks
Bristol Myers Squibb offers a comprehensive and competitive benefits package designed to support employee well-being and career growth. Benefits may vary by country and align with local market practices.
Key benefits include:
- Full-time employment with a globally respected biopharmaceutical company
- Exposure to large-scale global clinical development programs
- Opportunities for professional growth and skill development
- Supportive and inclusive work culture
- Emphasis on work-life balance and employee wellness
- Access to global learning platforms and career mobility opportunities
Eligibility and benefit structures may vary depending on location and employment conditions. CT Submission Specialist Jobs in Hyderabad
Why You Should Join
Joining Bristol Myers Squibb as a CT Submission Specialist provides the opportunity to work on high-impact clinical programs that directly contribute to regulatory submissions and patient safety. This role offers meaningful exposure to global submission processes, FDA requirements, and cross-functional clinical operations. CT Submission Specialist Jobs in Hyderabad
BMS empowers employees to bring their unique perspectives, develop professionally, and contribute to science-driven innovation. If you are passionate about clinical documentation, regulatory compliance, and making a real difference in patients’ lives, this role offers a rewarding and future-focused career path. CT Submission Specialist Jobs in Hyderabad
How to Apply
Interested and eligible candidates should apply through the official Bristol Myers Squibb careers portal using the job requisition ID R1596335.
Ensure your resume clearly highlights your clinical trial documentation experience, regulatory knowledge, and relevant systems exposure. Applications should be submitted online only through official channels. CT Submission Specialist Jobs in Hyderabad
FAQs
What is the job location for this role?
The position is based in Hyderabad, Telangana, India.
Is this a full-time position?
Yes, this is a full-time role.
Is travel required?
No travel is required for this position.
What experience is required?
Candidates should have 1–2 years of experience in clinical trial documentation management and overall pharmaceutical or CRO experience of approximately 3–4 years.
What systems experience is preferred?
Experience with Clinical Trial Master File systems and Veeva Vault Clinical is preferred.
Apply now to advance your career with Bristol Myers Squibb and be part of work that truly transforms patients’ lives through science.
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Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
