CT Documents Submission Lead

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.

Department Title and Description:

Clinical Trial Documents, Submissions and Disclosure

The Global Clinical Documents, Submissions and Disclosure organization regroup and unite various existing GCO functions under a single umbrella. Beside the maintenance and governance of the key Model Documents used in BMS sponsored clinical trials, this department is accountable for all the activities involved in the Clinical Trial Application process, those involved in the creation and maintenance of Informed Consent, the preparation of specific documentation in support of global Submissions, the fulfillment of our Disclosure obligations and other Transparency activities.

Purpose/Objective of the Job:

GCO leader accountable for submission ready delivery of CT documents across the BMS portfolio. Key point of contact for leaders in other functions working on Global Submissions, represents GCO on the submission teams and leads/manages the development and finalization of the GCO deliverables.

Key Responsibilities and Major Duties:

• Represents GCO on cross functional submission teams and is the key GCO point of contact for other functional leaders; has visibility of the short and medium term submission plans across R&D
• Ensure the compliance with regulatory requirements affecting clinical trial documents submission
• Drives the development and finalization of GCO operational submission deliverables for Integrated Oncology and Marketed Products. 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), Dossier Lead/Submission Managers and external partners (for Clinical Trial Support Specialists assigned to work streams)
• Tracks metrics, timelines, and other data for GCO deliverables partnering with the Operations Lead and study teams; perform trend analysis affecting the CT documents submission process; escalates observed trends and issues that may impact timely and quality of these deliverables and facilitates issues resolution
• Focuses on standardizing and streamlining processes and documents; identifies cross-functional opportunities for continuous improvement in the CT documents submission process and drives appropriate changes to improve quality and timeliness of these deliverables
• Provides functional oversight to off-shore partnership resources; work with off-shore partner to verify their delivery meets the terms of the Service Level Agreement; appropriately address/escalate issues and follow/up until resolution.

Degree/Certification/Licensure

• Knowledge equivalent to that attained with a Bachelor's degree in Life Sciences, Allied Health, Pharmacy, Nursing, a Master's degree is preferable

Experience:

• Candidate must have a minimum of a BA or BS Degree with approximately 8-10 yrs. of experience in clinical drug development.
• Broad knowledge of submission deliverables and strong project management skills.
• Experience in Clinical Operations, Submission Process, Regulatory or equivalent in the pharmaceutical/biotech industry
• Strong leadership competencies and influencing skills with senior leaders and cross-functional leaders.
• Demonstrated ability to matrix manage people and teams in a complex and diverse environment.
• Effective oral and written communication skills to influence, inform and guide a large scale global operational team.
• Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams.