Bristol-Myers Squibb Company

GCO Submission Lead

Location
Princeton, NJ, US
Posted
Jul 10, 2018
Ref
R1505280
Required Education
Bachelors Degree
Position Type
Full time

Description:

 

  • Represents GCO on cross functional submission teams and is the key GCO point of contact for other functional leaders
  • Drives the development and finalization of GCO operational submission deliverables for Integrated Oncology with planned expansion to Integrated Medicines. Submission deliverables include the following:
    • Financial Disclosure Tables and FD Package
    • BMS Employment check
    • Office of Scientific Information (OSI) Site Level Listing Data Sheet
    • Office of Scientific Information (OSI) Reviewer's Guide
    • CRF PID List and CRF Word list
    • Manage process for literature search updates
  • Coordinates requirements for output with Stats (GBS) and Dossier Lead/Submission Managers and NACC (for Clinical Trial Support Specialist assigned to work streams)
  • Tracks metrics, timelines, and other data for GCO deliverables partnering with the Operations Lead and study teams
  • Focuses on standardizing and streamlining processes and documents
  • Leads the Protocol Model Document Management Team
  • Leads and manages the BMS Protocol Model Document template & updates and represents BMS on TransCelerate Common Protocol Template Initiative

 


Requirements:

 

 

 

  • Candidate must have a minimum of a BA or BS Degree with approximately 8-10 yrs. of experience in clinical drug development.
  • Strong leadership competencies and influencing skills with senior leaders and cross functional leaders.
  • Effective oral and written communication skills to influence, inform and guide a large scale global operational team.
  • Broad knowledge of submission deliverables and strong project management skills.
  • Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams.