Bristol Myers Squibb (BMS) is hiring for the position of Scientific Writer I (PSSW) in Hyderabad, Telangana. The role focuses on coordinating and authoring scientific and regulatory documents supporting pharmaceutical development, submissions, approvals, and product life cycle management.
The position involves working with scientific, medical, and regulatory teams to develop clear, concise, and message-driven documents.
Job Details
| Job Details | Information |
|---|---|
| Company | Bristol Myers Squibb |
| Job Title | Scientific Writer I (PSSW) |
| Job Requisition ID | R1606939 |
| Location | Hyderabad, Telangana, India |
| Job Type | Full Time |
| Experience | Approximately 1–2 years of regulatory documentation or related experience |
| Reporting To | Senior Manager II |
Position: Scientific Writer I (PSSW)
The Scientific Writer I will coordinate and author documents required for regulatory submissions, integrating scientific, medical, and regulatory input from cross-functional development teams.
The role supports regulatory documents related to clinical pharmacology, clinical, and safety activities during development, submission, approval, and life cycle management of products.
Responsibilities
- Coordinate and author complex safety aggregate reports, risk management documents, and regulatory documents.
- Work on documents including:
- Investigator’s Brochures (IB)
- Development Safety Update Reports (DSUR)
- Periodic Benefit-Risk Evaluation Reports (PBRER)
- Clinical Study Reports (CSR)
- Protocols
- Coordinate and integrate scientific, medical, and regulatory input from development team members.
- Participate in relevant document subteams.
- Plan and manage timelines for assigned document components.
- Participate in document strategy sessions covering messaging, document flow, logic, and consistency.
- Maintain document prototypes and shells.
- Follow internal and external processes and guidelines.
- Manage the document review process.
- Resolve issues, errors, and inconsistencies with relevant team members.
- Ensure timely completion and high quality of assigned documents.
Eligibility & Qualifications
Candidates should meet the following requirements:
- Minimum BS/BA degree in Science.
- PhD, PharmD, or Master’s degree preferred.
- Approximately 1–2 years of regulatory documentation or related experience.
- Regulatory documentation experience is not mandatory if the candidate has related experience.
- PhD candidates in biological sciences and PharmD candidates are considered.
Required Skills
- Strong scientific writing skills.
- Experience authoring and managing scientific documents, including pharmaceutical regulatory documentation and/or publications in peer-reviewed journals.
- Ability to analyze and interpret complex data across a broad range of scientific disciplines.
- Basic understanding of global pharmaceutical drug development.
- Strong organizational and communication skills.
- Ability to manage timelines and work quality.
- Facilitation and interpersonal skills for working in cross-functional teams.
- Expertise in MS Office.
Application Details
