Job Posting: Submission Specialist – Be a Part of Life-Saving Innovations
Summary:
Bristol Myers Squibb (BMS), a leading global pharmaceutical company, is seeking a highly motivated and detail-oriented Submission Specialist to join our dynamic team in Hyderabad. In this role, you will play a crucial part in supporting global clinical trial submissions and regulatory documentation, contributing directly to the advancement of life-saving therapies. If you have a strong foundation in life sciences and a passion for regulatory affairs, this is an excellent opportunity to launch or elevate your career in the pharmaceutical industry.
About Bristol Myers Squibb:
At BMS, we are dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a legacy spanning decades, we are committed to pushing the boundaries of science and transforming lives through groundbreaking treatments. Join us in our mission to make a meaningful difference in the world.
Role Overview:
As a Submission Specialist, you will be responsible for supporting clinical trial applications (CTAs), managing document coordination, preparing regulatory submissions, and ensuring compliance with EU CTIS and global health authority requirements. This role requires exceptional organizational skills, meticulous attention to detail, and the ability to collaborate effectively with cross-functional teams across regulatory, quality, safety, medical writing, and operations departments.
Key Responsibilities:
- Documentation Management: Oversee the signing and execution of critical clinical trial documentation, including Power of Attorney documents and regulatory letters.
- CTA Support: Assist in the preparation, amendments, renewals, and closeout submissions of clinical trial applications.
- Compliance and Accuracy: Ensure the accuracy, compliance, and consistency of all clinical submission packages.
- CTIS Preparation: Prepare data and records within CTIS for EU and global submissions, ensuring adherence to all requirements.
- CRO and Country Team Coordination: Coordinate clinical trial application dossiers for Contract Research Organizations (CROs) and country teams, facilitating smooth and efficient submissions.
- Submission Tracking: Utilize tools like Veeva Vault and CTMS to track submissions, monitor progress, and ensure timely completion.
- Study Team Participation: Actively participate in global study tracking meetings, providing updates on submission status and escalating any potential delays or submission risks.
- Regulatory Knowledge Contribution: Contribute to the development and maintenance of global regulatory requirement repositories, ensuring accurate and up-to-date information.
- Process Improvement: Support automation, innovation, and continuous improvement initiatives within the regulatory submissions process.
Required Qualifications:
- Bachelor’s degree (BA/BSc) in Life Sciences, Pharmacy, Biotechnology, or a related field.
- 1-2 years of experience in the pharmaceutical, clinical research, or regulatory submissions field.
- Demonstrated knowledge of the clinical trial submission process and associated documentation requirements.
- Proven ability to work effectively in cross-functional global teams and manage multiple priorities simultaneously.
Preferred Skills:
- Experience with Veeva Vault (or similar electronic document management systems).
- Understanding of EU Clinical Trial Regulation (CTR) and Clinical Trial Information System (CTIS).
- Background in Clinical Research, ideally with experience in roles such as CRA, CTA, TMF management, or Regulatory Affairs.
- Exceptional communication and document handling skills.
Benefits & Culture:
BMS is committed to providing a supportive and rewarding work environment for our employees. We offer:
- Competitive Compensation & Benefits: A comprehensive package including competitive salary, health insurance, and other valuable benefits.
- Work-Life Balance: A focus on promoting work-life balance through flexible work arrangements and hybrid work options (dependent on role requirements).
- Growth Opportunities: Access to robust growth programs, certifications, and opportunities for global exposure to enhance your professional development.
- Inclusive Culture: A welcoming and inclusive culture that values diversity, equity, and inclusion, along with various employee support programs to ensure your well-being.
Ready to Apply?
If you are a passionate and driven individual looking to make a real impact in the pharmaceutical industry, we encourage you to apply for the Submission Specialist position at Bristol Myers Squibb. Join our team and be a part of something extraordinary!