Scientific Writer II
Job Posting – Hyderabad, India
Regulatory Affairs – R1572049
Full Time – 10/05/2023
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company that aims to discover, develop, and deliver innovative medicines to patients with serious diseases. With a focus on improving patient outcomes, BMS fosters a challenging and meaningful work environment. Through their diverse teams, they are able to make a difference in the lives of patients every day. To learn more about working at Bristol Myers Squibb, visit careers.bms.com/working-with-us.
Position Summary
To coordinate and author documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members.
Key Responsibilities
- Coordinate and author regulatory documents [eg, Investigator’s Brochures (IB), development safety update reports, periodic benefit-risk evaluation reports, clinical study reports (CSR), protocols, and high-level summary documents] 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 & Experience
- 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 pharmaceutical drug development.
- Demonstrated ability to manage timelines and quality of work using 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.
Keywords: Scientific Writer II, Regulatory Affairs, Bristol Myers Squibb, Hyderabad, India, Full Time, Pharmaceutical, Document Coordination, Authoring, Data Analysis
