Bristol Myers Squibb Company

Submission Senior Specialist, Submission Management

Location
Summit East, NJ, United States
Posted
Sep 12, 2020
Ref
R1529091
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 Summary / Objective

Global Submission Management is an organization that delivers compliant Health Authority submissions to support the BMS portfolio and provides submission strategies for drug development, drug approval, and maintenance of market approvals.

Position Responsibilities
  • Drives the execution of the Global Submission Plan through collaborating with team members and vendors.
  • Tracks the progress of all components for 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.
  • Assures regulatory guidelines are followed for electronic format and review both submission ready documents and dossiers for compliance to these guidelines.
  • Demonstrates a good working knowledge of global regulatory practices and requirements and supports liaisons, CMC, Safety, and other regulatory functions as appropriate.
  • In depth knowledge of dossier production and provides advice, mentoring, and guidance regarding regulatory and submission requirements, submission strategies, dossier content, and format.
  • Supports research for legal due diligence activities, document and submission management for acquisitions, partnerships and divestitures, assisting in internal audits and regulatory agency inspections
  • Other miscellaneous regulatory operational activities (e.g. US export waivers, translation document management, etc.)
  • Build/Manage CARA/PRISM Structures for Global CMC Submissions (CMC Submission Manager)


Degree/Experience Requirements
  • BA/BS degree and 3+ years of relevant regulatory/submissions experience. Publishing/eCTD submission experience highly desired.


Key Competency Requirements
  • Working knowledge of global regulatory practices, electronic submission guidelines and requirements.
  • Ability to lead 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 Submission Management matters.
  • Strong working knowledge of eCTD publishing standards is critical.
  • 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 as needed.
  • Travel as needed: 5%


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.