Senior Manager 1, Global Submission Management Clinical Trials, Global Regulatory Strategic Operations job opportunity at Bristol Myers Squibb.

Home Jobs In Poland Tag: Global Submission Management Clinical Trials, Global Regulatory Strategic Operations Senior Manager 1, Global Submission Management Clinical Trials, Global Regulatory Strategic Operations position at Bristol Myers Squibb


DatePosted 22 Days Ago bot
Bristol Myers Squibb Senior Manager 1, Global Submission Management Clinical Trials, Global Regulatory Strategic Operations
Experience: 7-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Global Submission Management Clinical Trials, Global Regulatory Strategic Operations

Copy Link Report
degreeAssociate
loacation Warsaw, Poland
loacation Warsaw....Poland

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 . Shape the Future of Clinical Trials with Us Join Our Global Development Team! Are you ready to support the BMS portfolio and sets the strategic business direction ? We’re seeking a passionate and experienced Senior Manager - Submission Management - Clinical Trials to support end-to-end regulatory activities for assigned projects, including leading the preparation and compilation of compliant clinical trial submissions for global health authorities and supporting continuous improvement initiatives. Position office based in Poland - Warsaw . Position Responsibilities: Regulatory Strategy & Submission • Collaborate with global and local stakeholders to define clinical trial submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines. • Assess core submission deliverables to ensure compliance, prepare and distribute global CTA dossiers, and manage data required for EU CTIS and substantial modifications. • Monitor and influence the regulatory assessment process, drive negotiations with stakeholders to resolve information requests, and communicate regulatory changes to ensure ongoing compliance. • Manage and track queries, commitments, and submissions with health authorities, collaborate with subject matter experts for responses, and provide periodic status updates on commitments. Continuous Improvement Initiatives • Drive initiatives that promote innovation and simplify processes to enhance efficiencies for BMS teams. • Contribute to the ongoing maintenance of regulatory requirements to ensure accurate and current regulatory information. • Ensure consistency of Clinical Trial Applications across projects, studies, and countries, aligning with regulatory standards and best practices. • Effectively communicate regulatory changes to the business to maintain compliance and support continuous improvement. Team Leadership •  Lead a team of direct reports managing resource and   allocation and assigned projects, provide training and mentoring to new staff, and support team with development and innovation. Education & Experience Requirements: • Degree Requirements BA/BS degree, science / technology field preferred. • 7+ years relevant regulatory submissions experience and people management experience. Key Competency Requirements: • Proficient knowledge of global regulatory practices, submission guidelines and requirements. • Collaborates with key stakeholders and resolves cross-functional issues independently and generates solutions by weighing risks and dependencies. • Support of other RISM members sharing expertise, providing guidance and serving as a SME. • Communicates effectively in English and simplifies complex topics for presentations and workshops. • Applies project management methodologies and strategic thinking to define objectives, track progress, and deliver results on increasingly more complex projects. • Proficient with desktop software and able to instruct others. Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned. Why Join Us? Be a key leader in global studies impacting diverse therapeutic areas. Work with talented teams across the US, India, Switzerland, and beyond. Grow your career in a supportive, forward-thinking environment. Make your mark in delivering high-quality, innovative clinical solutions. Ready to take your leadership to the next level? Apply now and help us shape the next generation of Submissions Manager - Clinical Trials! Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time , over a two-week period, with the flexibility to choose the days that align with your collaboration needs. We kindly ask all applicants to send their CV in English . #LI-Hybrid 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. Compensation Overview: Warsaw - PL: zł251,100 - zł304,272
 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws. 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. R1596269 : Senior Manager 1, Global Submission Management Clinical Trials, Global Regulatory Strategic Operations

Other Ai Matches

Manufacturing Team Lead, Liso-cel CAR-T, Manufacturing Operations Applicants are expected to have a solid experience in handling Liso-cel CAR-T, Manufacturing Operations related tasks
Senior Therapeutic Specialist, Cardiovascular Community - Frederick, MD Applicants are expected to have a solid experience in handling Cardiovascular Community - Frederick, MD related tasks
Associate Director, Senior AI Engineer Applicants are expected to have a solid experience in handling Senior AI Engineer related tasks
Senior Therapeutic Area Specialist, Cardiovascular Community - St Louis N, MO Applicants are expected to have a solid experience in handling Cardiovascular Community - St Louis N, MO related tasks
Associate Director, Medical & Access AI & Analytics Applicants are expected to have a solid experience in handling Medical & Access AI & Analytics related tasks
Sr. Director, Forecasting Pipeline, Oncology Applicants are expected to have a solid experience in handling Forecasting Pipeline, Oncology related tasks
Associate Director, Pipeline Forecasting, Neuroscience Applicants are expected to have a solid experience in handling Pipeline Forecasting, Neuroscience related tasks
IO Account Executive Applicants are expected to have a solid experience in handling Job related tasks
Specialist, Engineer I, MSAT Process Engineering Applicants are expected to have a solid experience in handling Engineer I, MSAT Process Engineering related tasks
Senior Director, Translational Research - Cell Therapy Applicants are expected to have a solid experience in handling Translational Research - Cell Therapy related tasks
Senior Therapeutic Area Specialist, Oncology- Omaha, NE Applicants are expected to have a solid experience in handling Oncology- Omaha, NE related tasks
Medical Science Liaison, Cardiovascular - Milvexian (North TX, OK) Applicants are expected to have a solid experience in handling Cardiovascular - Milvexian (North TX, OK) related tasks
DELEGUE HOSPITALIER IDF ONCOLOGIE Applicants are expected to have a solid experience in handling Job related tasks
Director, Global Trial Leader Applicants are expected to have a solid experience in handling Global Trial Leader related tasks
US Medical Learning, Sr. Manager, Hematology Applicants are expected to have a solid experience in handling Sr. Manager, Hematology related tasks
Associate Director, US Medical Learning, Cardiovascular (CV) Applicants are expected to have a solid experience in handling US Medical Learning, Cardiovascular (CV) related tasks
Senior Therapeutic Area Specialist, Oncology- St. Louis, MO Applicants are expected to have a solid experience in handling Oncology- St. Louis, MO related tasks
Therapeutic Area Specialist, Kumamoto, ONC Applicants are expected to have a solid experience in handling Kumamoto, ONC related tasks
Medical Science Liaison, Cardiovascular - Milvexian (MN, IA, WI, ND, SD) Applicants are expected to have a solid experience in handling Cardiovascular - Milvexian (MN, IA, WI, ND, SD) related tasks
Director, Business Development, Global Alliances Applicants are expected to have a solid experience in handling Business Development, Global Alliances related tasks
Senior Analyst, Financial Risk Management Applicants are expected to have a solid experience in handling Financial Risk Management related tasks
Associate III Manufacturing, Cell Therapy Applicants are expected to have a solid experience in handling Cell Therapy related tasks
Brand Lead CHAT, Cardiovascular (m/f/d) - fixed-term Applicants are expected to have a solid experience in handling Cardiovascular (m/f/d) - fixed-term related tasks