If you’re looking for Documentation Specialist jobs in Hyderabad, Bristol Myers Squibb (BMS) has opened an exciting opportunity for professionals with 1–2 years of experience in regulatory documentation, eCTD publishing, submission-ready formatting, and electronic document management systems.

This Documentation Specialist role is ideal for candidates with experience in Regulatory Affairs, Clinical Documentation, Medical Writing, eCTD Publishing, Clinical Study Reports (CSR), Protocol Documentation, Investigator Brochures (IB), and regulatory submissions. Working with one of the world’s leading biopharmaceutical companies, you’ll contribute to regulatory documentation that supports life-changing medicines.

Job Overview

About Bristol Myers Squibb

Bristol Myers Squibb (BMS) is a globally recognized biopharmaceutical company focused on discovering, developing, and delivering innovative medicines that transform patients’ lives. The company provides employees with excellent career growth opportunities, collaborative work culture, and exposure to global clinical development and regulatory operations.

Documentation Specialist Job Responsibilities

Selected candidates will be responsible for:

• Manage CARA structure assembly for regulatory documents.
• Support submission-ready formatting and publishing activities.
• Publish clinical documents including:
  • Clinical Study Reports (CSR)
  • Clinical Protocols
  • Investigator Brochures (IB)
  • Safety Aggregate Reports
• Collaborate with Global Submission & Regulatory Documentation (GSRD) teams.
• Assist external authors with PRISM/CARA workflows.
• Troubleshoot submission formatting and publishing issues.
• Perform Word remediation for externally authored documents.
• Import and publish regulatory documents using PRISM.
• Coordinate collection of ICH-compliant appendices.
• Support report-level content planning (RLCP).
• Ensure all regulatory documents meet eCTD submission requirements.
• Maintain documentation quality and publishing timelines.
• Work closely with cross-functional global regulatory teams.

Required Qualifications

Applicants should possess:

• Bachelor’s degree (BS/BA)
• Approximately 1–2 years of regulatory documentation experience
• Experience with:
  • Electronic Document Management Systems (EDMS)
  • Submission-ready formatting
  • Regulatory publishing workflows
• Knowledge of:
  • eCTD publishing
  • Clinical Study Reports
  • Investigator Brochures
  • Clinical Protocols
• Strong communication and organizational skills
• Ability to work in cross-functional matrix teams

Preferred Technical Skills

Candidates having experience in the following will be preferred:

• CARA
• PRISM
• Core Templates
• Microsoft Word Macros
• Model Documents
• Adobe Acrobat
• ISI Toolbox
• Electronic Document Management Systems
• eCTD Publishing
• Regulatory Documentation
• Submission Readiness
• Clinical Documentation
• Regulatory Operations

Salary (Estimated)

Based on similar Documentation Specialist roles in Hyderabad, the expected salary is:

₹8,00,000 – ₹12,00,000 per annum (CTC)

Actual compensation may vary depending on experience, skills, and internal compensation policies.

Why Join Bristol Myers Squibb?

Employees can expect:

• Global pharmaceutical career exposure
• Hybrid working opportunities (role dependent)
• Career development programs
• International regulatory documentation experience
• Collaborative global teams
• Competitive salary and benefits
• Inclusive work culture
• Learning and development opportunities
• Work on life-changing medicines

Who Should Apply?

This opportunity is suitable for professionals from:

• Regulatory Affairs
• Clinical Documentation
• Regulatory Publishing
• Medical Writing
• eCTD Publishing
• Clinical Operations
• Regulatory Operations

Candidates with experience in CSR publishing, Investigator Brochures, Clinical Protocol documentation, submission formatting, and electronic document management systems are strongly encouraged to apply.

How to Apply

Application Link