Sr. Project Specialist

Summit East, NJ, United States
Sep 17, 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.


Reporting to the Associate Director, Worldwide Patient Safety (WWPS), Safety Surveillance & Aggregate Safety Reporting, the Sr. Project Specialist facilitates Aggregate Safety Report (ASR) production activities across WWPS including PSURs, DSURs, US PSRs, Addendum reports, Renewal reports, as well as ad-hoc responses, medical surveillance to support early life cycle management, safety data summaries, and gap-analyses in publishing-ready format.

Responsibilities include, but are not limited to, the following:
  • Creating and maintaining project schedules
  • Ensuring all contributors are maintaining compliance with time lines
  • Tracking reports and their due dates
  • Planning, scheduling, coordinating and leading kick-off, strategy and comment resolution meetings
  • Planning, scheduling and coordinating resources (people and time) needed for report creation
  • Identifying all personnel involved in report preparation prior to kick-off meetings
  • Leading ongoing production meetings
  • Soliciting information for ASRs from identified contributors via email
  • Creating workflows (review and approval) for each of the reports in the document management system
  • Liaising with Medical Writing team members and other members of WWPS who support approved and development products and activities
  • Liaising with Regulatory Affairs to coordinate contributions for and synchronization of periodic reports
  • Liaising with other contributing groups as appropriate
  • Scheduling additional meetings as needed to resolve issues
  • Collaborating on the drafting of key SOPs & WPs related to processes
  • Performing other activities as needs arise in the context of ASRs
  • Representing the team and collaborating with business partners to promote streamlined processes
  • Supporting production activities for ad-hoc responses, medical surveillance to support early life cycle management, safety data summaries, and gap-analyses in publishing-ready format.

Skills/Knowledge Required:
  • Education: BA, BS, MA or MS in Business, Computer Science, Health Science or related discipline
  • Certification: PMP certification is desirable
  • Experience: Five (5) years relevant experience in pharma/biotech, preferably in PV; Three (3) years relevant experience in project planning desirable
  • Excellent skills and proficiency with Microsoft Office products: Word, Outlook, Excel, PowerPoint required; MS Project, Visio and Livelink (or similar document management platform) is desirable
  • Experience with safety databases (ARISg or similar)
  • Experience with document management systems and/or electronic shared work spaces, e.g., SharePoint
  • Ability to identify existing or potential deficiencies in procedures, and recommend solutions
  • Strong communication skills (both oral and written) and the ability to interact with various levels, both within WWPS as well as other parts of the organization
  • Knowledge of US, EU and ROW PV regulations is beneficial
  • Demonstrated ability to work independently with effective presentation and interpersonal skills to ensure a team-oriented approach
  • Ability to demonstrate a familiarity with principles of PV
  • Ability to work as part of a team, multi-task and meet internal and regulatory deadlines
  • Familiarity with safety database outputs, preferably ARISg and reporting tools, eg Business Objects

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.