Looking for Scientific Writer jobs in Hyderabad? Bristol Myers Squibb (BMS) is hiring a Scientific Writer II (PSSW) to support global regulatory submissions by authoring high-quality scientific and regulatory documents. This opportunity is ideal for professionals with experience in medical writing, regulatory writing, clinical documentation, pharmacovigilance, and clinical development.
If you have experience preparing Clinical Study Reports (CSR), Investigator’s Brochures (IB), Clinical Protocols, DSUR, PBRER, Risk Management Plans, or other regulatory documents, this role offers an excellent opportunity to work with one of the world’s leading biopharmaceutical companies.
Job Details
| Particular | Details |
|---|---|
| Position | Scientific Writer II (PSSW) |
| Company | Bristol Myers Squibb |
| Location | Hyderabad, Telangana |
| Job Type | Full-Time |
| Work Model | Hybrid (Site-by-Design) |
| Experience | Approximately 2โ4 Years |
| Requisition ID | R1604684 |
Key Responsibilities
As a Scientific Writer II, you will:
- Author and coordinate regulatory documents supporting global submissions.
- Prepare and review:
- Investigator’s Brochures (IB)
- Clinical Study Reports (CSR)
- Clinical Protocols
- Development Safety Update Reports (DSUR)
- Periodic Benefit-Risk Evaluation Reports (PBRER)
- Safety Aggregate Reports
- Risk Management Documents
- Coordinate scientific, medical, and regulatory inputs from cross-functional teams.
- Participate in document strategy discussions.
- Develop message-driven regulatory documents.
- Maintain document templates and document shells.
- Ensure compliance with internal SOPs and global regulatory guidelines.
- Review, edit, and improve document quality.
- Manage timelines and ensure timely document delivery.
- Collaborate with Clinical, Regulatory Affairs, Pharmacovigilance, Biostatistics, and Medical Affairs teams.
Eligibility Criteria
Candidates should possess one of the following:
- PharmD
- PhD in Biological Sciences or related scientific discipline
- M.Pharm
- M.Sc (Life Sciences)
- B.Pharm
- Bachelor’s or Master’s degree in relevant scientific disciplines with regulatory documentation experience
Required Experience
Applicants should have approximately 2โ4 years of experience in:
- Regulatory Medical Writing
- Scientific Writing
- Clinical Documentation
- Regulatory Documentation
- Pharmacovigilance Documentation
Experience authoring any of the following is preferred:
- Clinical Study Reports (CSR)
- Investigator’s Brochures (IB)
- Clinical Protocols
- DSUR
- PBRER
- Safety Aggregate Reports
- Risk Management Plans
Preferred Skills
Successful candidates should have:
- Excellent scientific and medical writing skills
- Strong English communication
- Regulatory documentation expertise
- Knowledge of global drug development
- Document management systems experience
- Understanding of document publishing workflows
- Cross-functional collaboration skills
- Timeline management
- Data interpretation abilities
- Attention to detail
- Regulatory compliance knowledge
Why Join Bristol Myers Squibb?
Bristol Myers Squibb offers employees:
- Competitive compensation
- Comprehensive employee benefits
- Hybrid work environment
- Global regulatory exposure
- Career growth opportunities
- Inclusive work culture
- International cross-functional collaboration
- Opportunity to work on innovative medicines
- Learning and development programs
Who Should Apply?
This opportunity is suitable for professionals working in:
- Medical Writing
- Scientific Writing
- Regulatory Affairs
- Pharmacovigilance
- Clinical Research
- Clinical Development
- Regulatory Documentation
- Safety Writing
How to Apply
