Senior Specialist, APMC Data Management job opportunity at Bristol Myers Squibb.

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DatePosted 4 Days Ago bot
Bristol Myers Squibb Senior Specialist, APMC Data Management
Experience: 3-years
Pattern: full-time
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APMC Data Management

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degreeAssociate
loacation Hyderabad - TS - IN, India
loacation Hyderabad - TS..........India

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Execute daily operations within regulatory systems such as Veeva Vault RIM, Quality Veeva Systems, and Regulatory Content Repositories, including extraction and review of submission registrations. Execute daily configuration activities within S AP Batch Release Hub including but not limited to product release test configuration, customer release check management, and issue resolution. Execute daily configuration activities within Change Control Restriction Management including but not limited to review of CMC assessments, confirmation and management of digital documents, data entry for alliance partner CMC assessments, and system configuration activities. Execute daily operations within Authorized Supply Chain Maps including but not limited to document extraction configuration, exception/issue handling and data entry. Execute daily operations within Document Data Extraction including but not limited to document extraction configuration, exception handling and data entry. Assess data from eCTD and CTD Module 3 documents to ensure accuracy, completeness, and consistency with relevant information from Quality and Supply Chain functions. Collaborate closely with CMC, Supply Chain, and Quality teams to align priorities, resolve issues, and provide status updates. Escalate unresolved deficiencies to the appropriate stakeholders. Escalate risks proactively to support the timely release of products. Identify and recommend opportunities for process improvement. Ensure compliance with GMP standards and BMS policies and procedures. Provide support for issue resolution across additional electronic systems, which may include (but are not limited to): Change Controls Deviations Change Control Restrictions Management SAP Batch Release Hub Authorized Supply Change Maps Document Data Extraction Qualifications & Experience Demonstrated understanding of Biologics, Pharmaceutical, and/or Cell Therapy operations and processes required. Understand product release activities for drug substance, drug product and finished product for US, EU and rest of world. Understand product lifecycle submissions for marketed products, including global post-approval changes, renewals, and regulatory updates within regulatory systems. Operates under routine supervision from a direct manager. Minimum 3 years of experience in a technical, quality, and/or regulatory role within the biopharmaceutical industry with demonstrated acumen in Quality Compliance or Operations preferred. Strong ability to assess data accuracy and consistency between manufacturing and regulatory information leveraging SAP, eCTD, and CTD Module 3 submissions. Solid working knowledge of Bills of Materials as they relate to the pharmaceutical supply chain. Prior experience with electronic quality management, regulatory management, or supply chain systems, including Veeva RIM, Veeva QMS, and SAP, preferred. Proven ability to build strong relationships through transparency, reliability, and consistent delivery on commitments. Capable of providing innovative ideas and making decisions that balance speed, quality, and risk. Basic knowledge of industry regulations, including 2 1 CFR Part 11, EU Annex 11, and Data Integrity principles. Demonstrates initiative, ownership, and accountability for assigned tasks. Collaborative mindset with the ability to work effectively within cross-functional teams. Strong communication and organizational skills, with an analytical approach to problem solving. Fluent in English, with proven professional working proficiency in reading, writing, and speaking, with the ability to contribute to clear documentation and presentations. Education Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or a related discipline. Travel Must have ability to travel abroad required (specifically for training purposes). If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:  https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1596850 : Senior Specialist, APMC Data Management

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