BMS Hiring Documentation Specialist (Regulatory Operations)
Are you seeking BMS Careers Hyderabad, a Documentation Specialist Job, or regulatory documentation eCTD publishing careers? Leading global biopharmaceutical innovator Bristol Myers Squibb (BMS) has announced an exciting vacancy for a Documentation Specialist within its Global Submission & Regulatory Documentation (GSRD) department in Hyderabad.
This electronic document structure assembly, Word template remediation, eCTD submission compliance, and global regulatory publishing vacancy operates under a full-time, site-by-design occupancy model (hybrid format with at least 50% onsite presence) in Hyderabad, Telangana. The position is open to life sciences, biology, or pharmacy graduates holding BS/BA, B.Pharm, M.Pharm, Pharm.D, or M.Sc degrees. Candidates must possess approximately 1 to 2 years of active regulatory documentation experience inside electronic document management systems (EDMS) and publishing workflows. The specialist will manage CARA database structures, format clinical study reports (CSRs), compile Investigator Brochures (IBs), coordinate ICH non-data driven appendices, and perform Word document remediation. To compile a professional corporate resume highlighting your CARA database skills, eCTD publishing tools, or document templates, read our guidelines on how to apply for healthcare and pharma jobs online.
📋 Job Overview
- Company: Bristol Myers Squibb (BMS)
- Position: Documentation Specialist
- Job Requisition ID: R1604158
- Job Location: Hyderabad, Telangana, India
- Employment Type: Full-Time
- Work Mode: Hybrid (Site-by-design, min 50% onsite)
- Experience: 1 – 2 Years in regulatory documentation / publishing
- Qualifications: BS / BA Degree / B.Pharm / M.Pharm / Pharm.D / BSc / MSc Life Sciences
- Expected Salary: ₹8,00,000 – ₹12,00,000 per annum (CTC Estimate)
💼 Key Responsibilities
- CARA Assembly: Facilitate assembly, structure setup, and management of regulatory documents in the CARA system.
- Publishing Support: Perform submission-readiness formatting and document publishing for Clinical Protocols, Investigator Brochures (IB), and Clinical Study Reports (CSR).
- Troubleshooting Help: Provide technical guidance to authoring teams regarding PRISM/CARA databases, Core Templates, and macro formatting.
- Word Remediation: Remediate externally authored Microsoft Word source files to ensure compliance with eCTD formatting guidelines.
- Appendices Collection: Coordinate the collection, formatting, and review of ICH-compliant clinical appendices for CSRs.
- Content Planning: Partner with cross-functional global submission teams to assist with Report Level Content Planning (RLCP).
To learn more about clinical databases and data operations, check out our guide on Clinical Data Management (CDM) Interview Questions.
🎓 Required Qualifications & Skills
- Education: Bachelor's degree (BS/BA) in Pharmacy, Life Sciences, or equivalent scientific discipline.
- Experience: 1 to 2 years of regulatory documentation experience inside electronic document management systems (EDMS).
- Formatting Tools: Proficiency in Microsoft Word template macros, model documents, and submission-ready style tools.
- Publishing Software: Working knowledge of Adobe Acrobat, ISI Toolbox, or eCTD publishing software.
- Collaboration: Interpersonal skills to work effectively with global virtual teams in a matrix structure.
- Systems (Preferred): Practical exposure to CARA, PRISM, or equivalent cloud document databases is an advantage.
For professionals interested in regulatory submissions, dossier compiling, and compliance checklists, read our guide on how to Crack Your Regulatory Affairs Interview.
🎁 Why Join Bristol Myers Squibb?
- Work for a premier global biopharmaceutical leader that discovers and delivers life-saving medicines.
- Gain exposure to complex international regulatory submissions and electronic document systems.
- Structured career growth paths across global regulatory operations, submission management, and medical writing.
- Collaborative workplace environment offering hybrid flexibility and competitive compensation benefits.
To test your basic knowledge of drug safety regulations, site protocols, and GCP guidelines before your screening assessments, try our interactive Clinical Research Associate (CRA) Quiz.
💡 Related Documentation Specialist Opportunities
BMS Documentation Specialists format clinical reports, structure CARA templates, and verify eCTD compliance. If you want to explore other clinical trial documentation, monitoring roles, and GCP site coordinator operations, check out the Clinical Research Coordinator (CRC) Guide.
📝 Resume Tips for BMS Candidates
- Detail EDMS Platforms: Explicitly mention if you navigated CARA, Documentum, or Veeva Vault platforms.
- Highlight Document Types: Specify if you formatted or published CSRs, Protocols, IBs, or safety reports.
- Mention Formatting Skills: Detail your experience with Microsoft Word macros, remediation workflows, or ISI Toolbox.
💬 BMS Documentation Specialist Interview Questions
- Q1. What does submission-ready formatting mean for an eCTD regulatory document?
Answer Guidance: Submission-ready formatting means the source document strictly follows style guide standards (font size, margins, table properties) and contains active navigation features (table of contents, hyperlinked headings, bookmarks) to ensure seamless conversion to eCTD PDF format. - Q2. How do you approach remediating an external clinical report Word file containing broken tables and incorrect styles?
Answer Guidance: I clear localized formatting overrides, apply standard corporate templates using styling macros, rebuild broken table structures using style sheets, and verify that the document hierarchy matches model requirements. - Q3. Explain the function of CARA and PRISM in global regulatory operations.
Answer Guidance: CARA is an electronic document management system used to structure, assemble, author, and review clinical/regulatory files. PRISM is used to manage submission content planning, import document structures, and coordinate publishing steps.
📖 How to Apply?
Before submitting your application, please read the step-by-step guidance on how to navigate the registration portal, fill out required forms, and format your application profile:
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Want to build a professional ATS-friendly resume tailored for Regulatory Documentation, eCTD Publishing, or Clinical Operations roles? Message us directly on our LinkedIn Company Page with the phrase "I want Resume Builder Service", and our expert team will connect with you:
📲 Message Us on LinkedIn🚀 Direct Application Links
If you are ready with your documents, submit your application directly via the official BMS Workday portal:
Apply Online – BMS Careers (R1604158-1)📄 Try Free ATS Resume Analyzer & Builder
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🚀 Launch Free ATS Resume Tool❓ Frequently Asked Questions
Q. Is this BMS position remote work-from-home?
No, this is a hybrid, site-by-design position based in Hyderabad requiring at least 50% onsite presence at the facility.
Q. What is the required experience for this role?
Applicants must possess approximately 1 to 2 years of regulatory documentation experience inside electronic document management systems (EDMS).
Q. Does BMS charge fees during the recruitment process?
No, Bristol Myers Squibb never requests payments, financial details, or bank accounts during the recruitment or application processes.
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