Regulatory Documentation Specialist
3 weeks ago
Bristol Myers Squibb is seeking a highly skilled Regulatory Documentation Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for coordinating and authoring complex documents required for regulatory submissions. Your expertise will ensure the coordination and integration of scientific, medical, and regulatory input from cross-functional team members.
Key Responsibilities
- Author complex clinical documents, such as Investigator's Brochures (IB), Protocols, Phase 2/3 Clinical Study Reports (CSR), and Common Technical Document (CTD) summary documents, in compliance with BMS documentation standards and worldwide regulatory requirements.
- Participate in relevant document subteams and ensure effective planning and management of timelines for all components of assigned documents.
- Collaborate with cross-functional teams to develop messaging, document flow, logic, and consistency for assigned projects.
Qualifications & Experience
- PharmD/PhD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 5 years of pharmaceutical regulatory documentation experience.
- Demonstrated strong writing skills in authoring and managing the production of IB, Safety Aggregate Report, Clinical Protocols, and/or CSR.
- Excellent analytical and interpretive skills, with the ability to analyze and interpret complex data from a broad range of scientific disciplines.
Why Work at Bristol Myers Squibb?
BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.
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