Duties/Responsibilities

- Coordinate and author regulatory documents [e.g., Investigators 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 Masters/Bachelors 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 pharmaceutical drug development.
- Demonstrated ability to manage timelines and quality of work using solid organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
- Working knowledge of a document management system and basic knowledge of the document publishing process.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

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