Bristol Myers Squibb Jobs For BSc Life Sciences Document Specialist, Apply Online
GTAC Document Specialist
About Bristol Myers Squibb
Bristol Myers Squibb is a leading global pharmaceutical company committed to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Our work is focused on building sustainable and innovative solutions to improve the lives of patients worldwide. As an employer, we offer a challenging, meaningful, and life-changing work environment where you can grow and thrive through unique opportunities uncommon in scale and scope. Join us in making a difference and taking your career farther than you thought possible.
Position: GTAC Document Specialist
Location: Hyderabad, India
Department: Clinical Development
Job Code: R1574546
Employment Type: Full Time
Start Date: 11/10/2023
As a GTAC Document Specialist at Bristol Myers Squibb, you will play a vital role in supporting global clinical trials and engaging with clinical trial vendors across multiple service categories. Your responsibilities will involve document and Clinical Trial Application (CTA) package creation, ensuring compliance with regulatory standards and ethical practices, and maintaining collaborative working relationships with clinical investigator sites. This is a challenging position that offers meaningful work and the opportunity to make a significant impact on the lives
of patients.Key Responsibilities
- Manage and execute centralized activities in support of global trials, with an emphasis on clinical documentation.
- Interact with clinical study sites, Central/Local IRB/IECs, CROs/vendors, and other functional areas within BMS.
- Support outsourcing activities by coordinating with operational teams, support groups, and service providers.
- Initiate and manage start-up documentation activities for global clinical trials.
- Review and resolve outstanding issues with regulatory documentation, ensuring submission to the electronic Trial Master File (eTMF).
- Responsible for site activation and conducting quality control activities as applicable.
- Update and review various study-related clinical systems.
- Arrange certified translation of study level documentation.
- Act as a single point of contact for centralized study activities during start-up and ongoing maintenance.
- Manage correspondence with investigative sites, including protocol amendments and IRB/IEC approval.
- Provide ongoing support for Central/Local IRB/IEC process and submission of safety events.
- Ensure accuracy and completeness of documents in the eTMF through review and quality control activities.
- Communicate with sites and study teams regarding centralized study activities.
- Lead or manage the ongoing collection and review of Financial Disclosure Forms.
- Assist with the generation of CSR appendices and creation of standardized document templates.
Qualifications & Experience
- Bachelor’s degree in legal, life science, business administration, or equivalent experience. Advanced degree is a plus.
- 1-2 years of relevant clinical development and operational experience in the pharmaceutical, biotech, CRO, or similar fields.
- Hands-on experience with preparing, reviewing, and submitting regulatory documentation to IRB/IECs and Regulatory Agencies.
- Familiarity with ICH/GCP guidelines and regulatory guidelines/directives.
- Strong organizational, time-management, analytical, and decision-making skills.
- Excellent communication skills in English (written and oral).
- Proficiency in MS Office suite, SharePoint, and CTMS (Veeva Vault experience preferred).
- Experience in managing key stakeholders and working within a matrix structure.
- Proven time management skills and ability to manage multiple priorities.
- Adaptability and ability to perform well in an ambiguous and complex work environment.
Keywords: Bristol Myers Squibb, Document Specialist, Clinical Development, Clinical Trials, Pharmaceutical, Biotech, CRO, Regulatory Documentation, ICH/GCP, Communication Skills, MS Office, CTMS, Stakeholder Management, Time Management, Adaptability. Bristol Myers Squibb Jobs For BSc Life Sciences Document Specialist, Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
