Clinical Trial Submission Specialist Job at BMS India

BSc CT Submission Specialist – Hyderabad | BMS

Life Sciences graduates required for CT Submission Specialist role in Hyderabad at Bristol Myers Squibb. Clinical trial documentation experience preferred.

Bristol Myers Squibb (BMS) is hiring a CT Submission Specialist, also referred to as GDO Submission Document Specialist, for its Research & Development operations in Hyderabad. This role sits within Global Development Operations and directly supports FDA and global regulatory submissions for clinical trials. It is a documentation-intensive, compliance-driven position suited for professionals with experience in clinical trial documentation, submission readiness, and regulated drug development environments. If you want to work on global clinical submissions that directly impact patient access to innovative therapies, this role offers rare depth and long-term career value.

Company Overview

Bristol Myers Squibb is a global biopharmaceutical leader known for advancing science in oncology, immunology, cardiovascular disease, and cell therapy. The company operates with a clear mission of transforming patients’ lives through science, supported by strong ethics, regulatory rigor, and scientific excellence.

BMS India plays a critical role in global clinical development, regulatory operations, and trial delivery support. Teams in Hyderabad collaborate closely with US and EU stakeholders, supporting FDA submissions, clinical transparency, and trial integrity. Working at BMS means exposure to global regulatory standards, advanced clinical systems, and high-impact programs that shape the future of medicine.

Job Role & Responsibilities

The CT Submission Specialist supports the creation, coordination, and quality review of operational deliverables for clinical trial and FDA submissions. This role requires precision, regulatory awareness, and the ability to manage multiple timelines in a matrix environment.

Core Submission & Documentation Responsibilities

• Supporting the GDO Submissions Document team in preparation and quality checks of clinical submission deliverables
• Developing and finalizing protocol-related submission documents in line with timelines and quality expectations
• Ensuring all documents are submission-ready compliant (SRC) and formatted according to regulatory standards
• Supporting FDA and global regulatory submissions through accurate document coordination

Clinical Trial Support & Collaboration

• Partnering with Clinical Trial Support Specialists (CTSS) for timing and creation of submission documents
• Supporting preparation of CSR appendices, financial disclosure tables, and related clinical documents
• Coordinating with cross-functional teams to ensure document completeness and readiness

Compliance, Risk & Issue Management

• Identifying documentation risks, gaps, or inconsistencies and addressing them proactively
• Escalating submission-related risks to functional management when required
• Applying critical thinking to develop mitigation and resolution strategies
• Responding promptly to action items in fast-paced clinical trial environments

Systems & Process Responsibilities

• Working with Clinical Trial Master File (TMF) systems and document management platforms
• Using clinical systems such as Veeva Vault Clinical, CTMS, SharePoint, and other trial-enabling technologies
• Supporting document lifecycle management aligned with ICH-GCP and regulatory directives

Eligibility / Qualifications

Educational Qualifications

Candidates must possess at least one of the following qualifications:

BSc Life Sciences, BSc Biotechnology, BSc Microbiology, BSc Biochemistry, BSc Chemistry, Bachelor’s Degree in Business Administration, Clinical Research, Pharmaceutical Sciences

An advanced degree in Life Sciences, Clinical Research, or related fields is considered an added advantage.

Experience Requirements

• 1–2 years of relevant experience in clinical trial documentation management or a related clinical operations role
• Overall 3–4 years of experience in pharmaceutical, biotech, or CRO environments preferred
• Hands-on understanding of the drug development process and clinical trial lifecycle
• Demonstrated knowledge of ICH-GCP guidelines and regulatory submission standards
• Experience using Clinical Trial Master File systems or equivalent platforms
• Prior exposure to Veeva Vault Clinical is strongly preferred
• Proficiency with MS Office Suite, SharePoint, CTMS, and clinical portals

Key Competency Requirements

• Strong project management and organizational skills
• Ability to manage multiple priorities and tight submission timelines
• Experience working in cross-functional and multi-cultural matrix teams
• Strong analytical and decision-making capabilities
• Ability to work independently with minimal supervision
• Excellent written and verbal communication skills
• Strong understanding of protocol-related documentation and core templates

Location & Salary

• Job Location: Hyderabad, Telangana
• Work Model: Site-by-design (hybrid model with required onsite presence)
• Employment Type: Full-time
• Travel Requirement: No

Application Process

Interested candidates should apply directly through the official Bristol Myers Squibb career portal using the link below:

Apply Here: https://jobs.bms.com/careers/job/137477570717

Requisition ID: R1596335 – CT Submission Specialist

Applicants are encouraged to apply even if they do not meet every listed requirement, as BMS values potential, learning ability, and diverse experience.

Why This Role Matters in Clinical Research & Pharma

Clinical trial submissions are a critical bridge between scientific research and regulatory approval. This role contributes to:

• Timely and compliant FDA submissions
• Integrity and transparency of clinical trial data
• Acceleration of innovative therapies to patients
• Global regulatory compliance across development programs

Professionals in clinical documentation and submission roles are in high demand due to increasing regulatory scrutiny, complex trial designs, and global transparency requirements.

FAQs – CT Submission Specialist

Who can apply for this role?

Candidates with a bachelor’s degree in Life Sciences or related disciplines and relevant clinical documentation experience can apply.

Is CRO experience acceptable?

Yes. Experience in CRO, pharmaceutical, or biotech environments is highly relevant.

Is Veeva Vault experience mandatory?

It is not mandatory but strongly preferred.

Does this role involve travel?

No. This position does not require travel.

Is this a hybrid role?

Yes. This is a site-by-design role with required onsite presence for collaboration.

Summary Table

Company	Bristol Myers Squibb
Vacancies	CT Submission Specialist (GDO Submission Document Specialist)
Required Education	BSc Life Sciences, Biotechnology, Microbiology, Biochemistry, Chemistry, Business Administration
Experience	1–2 years clinical documentation experience; 3–4 years pharma/biotech/CRO exposure preferred

Tagged as: Pharma Jobs in Hyderabad