Associate Director, Precision Medicine Digital Health job opportunity at Bristol Myers Squibb.

Home Jobs In Poland Tag: Precision Medicine Digital Health Associate Director, Precision Medicine Digital Health position at Bristol Myers Squibb


bot
Bristol Myers Squibb Associate Director, Precision Medicine Digital Health
Experience: 7-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Precision Medicine Digital Health

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 . Position Summary The Associate Director, GRS PMDH leads global regulatory strategies to support the development and approval of biomarkers, companion diagnostic tests, digital health solutions, and other devices associated with pharmaceutical products across therapeutic areas. This role involves assessing regulatory landscapes, managing regulatory risks, and developing global filing strategies. The Associate Director co-leads marketing application submission teams, ensures consistent responses to global Health Authority (HA) queries, and integrates regional regulatory strategies into global development plans. Additionally, the role includes providing input into protocol development, responding to Clinical Trial Application (CTA) queries, and contributing to the development of target labeling. The position requires a strong background in regulatory affairs, team leadership, and project management within the medical device and pharmaceutical industries. Duties/Responsibilities Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas. Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers. Ensure consistent positions are presented in responses to global Health Authority (HA) queries. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the Global Regulatory sub-team, develop global submission plans and HA interaction plans. Provide input into the development of protocol synopses and protocols. Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines. Contribute in the developing of target labeling. Reporting Relationship Executive Director, Regulatory Affairs, Precision Medicine and Digital Health Qualifications Bachelor's degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with at least 7 years of US or EU Medical Device Regulatory Affairs experience Specific Knowledge, Skills, Abilities: Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance. Experience utilizing leadership techniques to drive a team through the stages of team development. Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives. Experience with clinical trial assays (CTA) in drug clinical trials in communicating between Diagnostic sponsor and Drug sponsor. Experience as a member of Global Regulatory sub-team, project working groups, or comparable experience in the industry. Experience with communication of regulatory strategy, issues, and risks in written and verbal format within teams, across functions and to governing bodies. Ability to apply project management techniques within teams and effectively manage meetings. Demonstrated ability to breakdown complex, scientific content into logical components. Ability to coordinate global activities, facilitate issue resolution and conflict management. Demonstrated ability to drive quality decision-making and ability to organize/prioritize tasks. Demonstrated ability to negotiate with and influence others. Understanding of strategic and tactical role for the drug development process Understanding of general global regulatory requirements for drugs in development. Understanding of R&D process and specific regulatory responsibilities/deliverables for the company decision points. 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: zł361,740 - zł438,337
 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. R1596272 : Associate Director, Precision Medicine Digital Health

Other Ai Matches

Senior Manager, Learning Global Capability Center Business Implementation Partner Applicants are expected to have a solid experience in handling Learning Global Capability Center Business Implementation Partner related tasks
Validation Engineer II Applicants are expected to have a solid experience in handling Job related tasks
Manager, Health Systems Analytics Applicants are expected to have a solid experience in handling Health Systems Analytics related tasks
Account Executive, MAVA Applicants are expected to have a solid experience in handling MAVA related tasks
Associate Director, Structured Benefit-Risk Assessment Lead Applicants are expected to have a solid experience in handling Structured Benefit-Risk Assessment Lead related tasks
Senior Therapeutic Area Specialist, Neuroscience MS Applicants are expected to have a solid experience in handling Neuroscience MS related tasks
Senior Business Analyst Applicants are expected to have a solid experience in handling Job related tasks
Clinical Development Lead Prostate (ACP3) Applicants are expected to have a solid experience in handling Job related tasks
Sr. Sales Rep Applicants are expected to have a solid experience in handling Job related tasks
Associate Director, Copay and Affordability Applicants are expected to have a solid experience in handling Copay and Affordability related tasks
RayzeBio Scientist, Radiochemistry Applicants are expected to have a solid experience in handling Radiochemistry related tasks
Director, Global Patient Advocacy and Society Engagement Applicants are expected to have a solid experience in handling Global Patient Advocacy and Society Engagement related tasks
Sr. Manager, TMF System Business Lead Applicants are expected to have a solid experience in handling TMF System Business Lead related tasks
Clinical Trial Manager Applicants are expected to have a solid experience in handling Job related tasks
MAVA Account Executive Applicants are expected to have a solid experience in handling Job related tasks
(Sr.) Account Executive/ (Sr.) Medical Rep(Mava) Applicants are expected to have a solid experience in handling Job related tasks
Senior Therapeutic Area Specialist, Neuroscience - Zeposia - Houston, TX Applicants are expected to have a solid experience in handling Neuroscience - Zeposia - Houston, TX related tasks
Account Executive Applicants are expected to have a solid experience in handling Job related tasks
Senior Manager, Direct Tax, Germany Applicants are expected to have a solid experience in handling Direct Tax, Germany related tasks
Specialist, Associate Operations Engineer, Cell Therapy in Devens, MA Applicants are expected to have a solid experience in handling Associate Operations Engineer, Cell Therapy in Devens, MA related tasks
Specialist Benchtop IT Systems Applicants are expected to have a solid experience in handling Job related tasks
Manager Quality Assurance Disposition Support Applicants are expected to have a solid experience in handling Job related tasks
Senior Manager, Business Operations, QC Enabling & Analytical Sciences Applicants are expected to have a solid experience in handling Business Operations, QC Enabling & Analytical Sciences related tasks