Bristol Myers Squibb

Specialist, Submission Management

4 days agoPrinceton, NJ

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Job Responsibilities:

  • Tracks, collects and reviews all components for routine submissions to Health Authorities
  • Interacts with responsible parties for quality submission documents for routine submissions
  • Troubleshoots issues found in components received and interacts with responsible parties for clarification or revision
  • Assist with the translation document management activities
  • Other miscellaneous regulatory operational activities (e.g. US export waivers, etc.) as needed
  • Coordinate non-eCTD submissions with ISL Intercon Team
  • Independently prepare Cover Letter, FDA Forms and submission content plan for routine maintenance Investigational submissions
  • Coordinate submission publishing with vendor/supplier
  • Update Verity with US planned submissions and update entries with submitted submissions
  • Perform submission verification on published submissions to confirm eCTD compliant

Requirements:
  • BA/BS degree, science / technology field preferred
  • 0-2 years pharmaceutical experience
  • Foundational knowledge of global regulatory practices, electronic submission guidelines and requirements
  • Communicates questions and issues as they arise with possible solution
  • Supports other functions as appropriate
  • Participates in submission team meetings
  • Effective written and verbal communication skills
  • Works with supervision
  • Ability to prioritize and strong attention to detail
  • Must be comfortable working in an environment that utilizes electronic docbases, databases, publishing and computer systems (Microsoft Office, Outlook, eCTD viewers and web based applications) and be technically savvy with such systems.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Job ID: BristonMyers-R1535573