At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over reliable diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

· Duties/Responsibilities

· Coordinate and author regulatory documents [eg, Investigator's Brochures (IB), development safety update reports, periodic benefit-risk evaluation reports, clinical study reports (CSR), and protocols] ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members.

· Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
· Participate in document strategy sessions,



including messaging, document flow, logic, and consistency for assigned projects.
· Maintain document prototypes and shells.
· Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.
· Review and edit documents as required.

Qualifications
PharmD/PhD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 2-4 years of regulatory documentation. All PhD in biological sciences and PharmD candidates are considered.
Demonstrated strong writing skills in authoring and managing the production of IB, Safety Aggregate Report, Clinical Protocols, and/or CSR.
Ability to analyze and interpret complex data from a broad range of scientific disciplines.
Understanding of global p

📌 Scientific Writer II (Hyderabad)
🏢 Bristol-Myers Squibb
📍 Hyderabad