Pharma Scientific Writer Job at Bristol Myers Squibb
About the Company
Bristol Myers Squibb is currently looking for a talented Pharma Scientific Writer to join their team. With a location in Hyderabad, Telangana, India, this position offers the opportunity to work from the office 2-3 days a week.
In this role, you will be responsible for coordinating and authoring complex documents required for regulatory submissions. This includes ensuring integration of scientific, medical, and regulatory input from cross-functional team members.
- Coordinate and author complex clinical documents such as Investigator’s Brochures (IB), Protocols, Phase 2/3 Clinical Study Reports (CSR), briefing documents, Common Technical Document (CTD) summary documents, and responses to Health Authority queries.
- Ensure good documentation principles by maintaining organization, clarity, and scientific standards.
- Ensure consistency between text, tabular presentations, and graphical displays.
- Comply with BMS documentation standards and worldwide regulatory requirements.
- Plan and manage timelines for all components of assigned documents.
- Participate in document strategy sessions to establish messaging, document flow, logic, and consistency for assigned projects.
- Participate in document prototyping sessions and maintain document prototypes and shells.
- Manage the review process, resolve issues, errors, or inconsistencies with team members, and ensure optimal communication between authoring team and development team members.
- Review and edit documents as required.
Qualifications & Experience
- PharmD/PhD in a relevant scientific discipline or Master’s/Bachelor’s degree with approximately 4-8 years of pharmaceutical regulatory documentation.
- 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 various scientific disciplines.
- Good understanding of global pharmaceutical drug development and requirements for documentation authoring supporting regulatory submissions.
- Strong 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.
Whatever your career goals, Bristol Myers Squibb is here to help you reach them!
Apply for this position here.
Keywords: Pharma Scientific Writer, Bristol Myers Squibb, Hyderabad, Telangana, India, regulatory submissions, clinical documents, scientific writing, pharmaceutical drug development. Pharma Scientific Writer Job at Bristol Myers Squibb. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.