Job Title: Submission Specialist
Location: Hyderabad, Telangana, India
About Bristol Myers Squibb
Bristol Myers Squibb is a leading global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines for patients with serious diseases. Our mission is to transform patients’ lives through science. We offer a dynamic and collaborative work environment where employees can grow their careers and make a meaningful impact on the world.
Summary
We are seeking a highly motivated and detail-oriented Submission Specialist to join our Regulatory Operations team in Hyderabad. This role offers an exciting opportunity to contribute to global clinical trial applications, specifically in the area of CTA (Clinical Trial Application) documentation and CTIS (Clinical Trial Information System) workflows. As a Submission Specialist, you will play a critical role in ensuring the accuracy, consistency, and compliance of our clinical trial submissions. If you have 1-2 years of experience in the pharmaceutical industry and are eager to develop your expertise in regulatory submissions, this position is an excellent opportunity for career growth and advancement.
Key Responsibilities
- Document Management: Manage the signing and coordination of essential clinical trial documents, such as Power of Attorney agreements.
- CTA Preparation: Support senior team members in the preparation of CTAs, including initial filings, protocol amendments, and Clinical Study Report (CSR) distribution.
- Dossier Preparation and Distribution: Prepare and distribute global Clinical Trial Application dossiers and substantial amendments, ensuring timely and accurate submission.
- CTIS Data Entry: Enter and update data within the CTIS for global CTA dossiers, maintaining data integrity and compliance with regulatory requirements.
- Data Consistency: Ensure accuracy and consistency across studies, countries, and submission packages, adhering to established standards and guidelines.
- Study Tracking Meetings: Participate in study CTA tracking meetings to monitor timelines, identify potential issues, and maintain dossier quality.
- Cross-Functional Collaboration: Liaise with global teams, including Clinical Operations, Safety, Medical, Quality, and Protocol Management, to facilitate seamless submission processes.
- Compliance: Ensure compliance with BMS Standard Operating Procedures (SOPs), global regulations, and submission guidelines.
- System Utilization: Utilize systems such as Veeva and Clinical Trial Management System (CTMS) for tracking and reporting CTA content effectively.
- Global Requirements Repository: Contribute to the maintenance and updates of the Global Country Requirements Repository, ensuring accurate and up-to-date information.
- EU CTR Implementation: Support the implementation of the EU Clinical Trial Regulation (CTR), participate in innovation initiatives, and contribute to process simplification efforts.
Qualifications and Experience
- Educational Requirements: Bachelor’s or Master’s degree in Science or Technology (preferred).
- Experience: 1-2 years of experience in the pharmaceutical or clinical research/operations field.
Key Skills
- Regulatory Submissions: Understanding of regulatory submissions for non-US clinical trial applications.
- Technical Proficiency: Familiarity with CTA documentation, CTIS, CTMS, and Excel Trackers.
- Coordination and Communication: Strong coordination, communication, and documentation skills.
- Teamwork: Ability to work effectively with supervision and within cross-functional teams.
Why Join Bristol Myers Squibb?
- Global Impact: Work on global-scale clinical research documentation, contributing to the development of life-changing medicines.
- Career Development: Opportunities for career growth, continuous learning, and cross-functional exposure.
- Comprehensive Benefits: Competitive compensation and benefits package, including health insurance, retirement plans, and paid time off.
- Work-Life Balance: Flexible working environment to support a healthy work-life balance (Hybrid eligibility varies by role).
- Mission-Driven Culture: Be part of a company committed to transforming patients’ lives through innovative science.
Job Location
Hyderabad, Telangana – India
Work Model: On-site / Site-by-design (Hybrid eligibility varies by role)
How to Apply
Interested candidates are encouraged to apply through the company’s careers website. We look forward to receiving your application and exploring the opportunity to welcome you to the Bristol Myers Squibb team.