Bristol Myers Squibb Company

Submission Specialist, Submission Management

Jersey City, NJ, United States
Aug 20, 2020
Required Education
Bachelors Degree
Position Type
Full time
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.

Position Responsibilities
  • Collects and reviews all components for routine dossier submissions to Health Authorities.
  • Interacts with responsible parties to help ensure that components are received in a timely manner for routine submissions.
  • Tracks the progress of all components for routine dossier submissions to Health Authorities.
  • Interacts with responsible parties to aid in ensuring that components are received in a timely manner and provide direction to assure quality results are produced.
  • Troubleshoots issues found in components received and interacts with responsible parties for clarification or revision
  • Assures regulatory guidelines are followed for electronic format and review both submission ready documents and dossiers for compliance to these guidelines.
  • Demonstrates a working knowledge of regulatory practices and requirements and supports other regulatory functions as appropriate
  • Other miscellaneous regulatory operational activities (e.g. US export waivers, translation document management, etc.) as needed
  • Build/Manage CARA/PRISM Structures for Global CMC Submissions (CMC Submission Specialist)

Experience Required:
  • 2+ years relevant pharmaceutical experience
  • BA/BS degree, science / technology field preferred experience

Ideal Candidates Would Also Have:
  • Basic knowledge of global regulatory practices, electronic submission guidelines and requirements.
  • Have experience being a member of multi-functional submission teams and track progress of dossier components to ensure timely execution of submissions.
  • Ability to interact and negotiate with outside suppliers on Global Dossier Management matters.
  • Exhibit strong attention to detail, have good organization, communication, and collaboration skills, and seamless multi-tasking abilities to be able to work simultaneously on multiple projects.
  • Needs to be able to effectively adjust plans to deal with change and be flexible. Must be able to think in a clear, decisive manner under submission timeline pressures.
  • 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.
  • Be flexible in working hours; sometimes including nights, holidays and weekends.

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.