Bristol-Myers Squibb Company

Submission Publishing Process Manager

Location
Princeton, NJ, US
Posted
Jun 30, 2018
Ref
R1507665
Required Education
Bachelors Degree
Position Type
Full time
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.

Summary:

The Regulatory Submission Publishing Process Design Manager manages and coordinates the company's electronic and internal processes that support the timely, compliant and accurate delivery of submission publishing services.

Responsibilities:
  • Subject Matter Expert for all document and submission publishing processes and global Health Authority (FDA, EU, and ROW depending on specific role) requirements, including time-sensitive information (e.g. weekly, monthly, annual deliverables)
  • Primarily accountable for overseeing the detailed processes associated with Health Authority regulations, internal BMS processes, ensuring that all new changes to HA electronic guidances are known, implications assessed, and all involved know how to respond to such changes.
  • Primarily accountable for ensuring all other R&D functional changes or systems implementations that engage with Global Dossier Management are well integrated into current processes.
  • Leads implementations or new uses of eCTD backbone to submit to HAs; leads efforts to onboard new countries to support the use of eCTD in their countries. Identification of upcoming impacts, understanding business requirements, negotiation of design and process development, roles and responsibilities, timing and budget implications.
  • Leads efforts to prepare for future guidance-related implications to publishing and be sure that our vendor-provided information meets their needs.
  • Manages troubleshooting of eCTD document and submission publishing challenges, and provides direction to team and external service providers; ensures publishing team is coordinated and working in the most simplified manner to produce consistent deliverables.
  • Coordinates submission management tasks for acquisitions, divestments, and 3rd party partnership agreements on behalf of BMS.
  • Provides feedback to management related to potential risks, issues and continuous improvement opportunities to ensure BMS' relationship with our providers remains positive and effective.
  • Participates in service provider negotiations for operational improvements and understand contractual obligations.
  • Leads communications with various stakeholders and management, and collaborates and determines best next steps; manages efforts to resolve upstream process breakdowns impacting publishing.
  • Ongoing monitoring and management of key stakeholders; assesses and partners with non-BMS entities to help support their needs associated with publishing (e.g. IMD and PRA).


Desired Experience

Required:
  • BA/BS degree, science / technology field or 15+ years Pharma industry experience
  • 5+ years relevant regulatory / submissions experience
  • eCTD publishing expertise
  • HA electronic requirements knowledge associated with document and submission publishing


Ideal Candidates Would Also Have:
  • Demonstrated ability to organize/prioritize tasks
  • Ability to interact with all levels of the organization in a professional manner
  • Demonstrated ability to facilitate issue resolution and conflict management, and negotiate to acceptable outcomes and influence others
  • Experience working with external publishing service providers and understanding contractual language and how that relates to execution of work.


Other qualifications:
  • US military experience will be considered towards industry experience requirements