Submission Publishing Workflow Manager
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.
Focused mainly on IND type publishing, manage workflow of all submission publishing requests (all submission formats-- IND/NDA/BLA/MAA, etc.) between BMS and our service providers. Build, maintain and monitor systems and processes to ensure that quality and on-time metrics are available and met by our multiple service providers. Work closely with both service providers and BMS teams to ensure daily awareness of priorities for publishing. Develop and implement consistent processes to ensure and quality deliverables that meet BMS and global Health Authority electronic requirements and BMS expectations. Primarily responsible for improving and simplifying how BMS and service providers interact to ensure alignment and efficiency, focusing on processes that can be the same or similar to one another across service providers. Drive the implementation of systems and processes to improve and simplify the movement of data between BMS and service providers.
Accountable for assessing, from a Regulatory perspective, how to prioritize work requests and ensure that the highest priority items are highlighted appropriately and communicated to our service providers on a daily basis. Provide 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, identify potential risks to the relationship and being inquisitive about both their and our procedures to improve speed and quality of our deliverables. Responsible for identifying technology opportunities by working closely with our BMS IT partners. Understand contractual obligations and ensure BMs and service providers meet contractual obligations by partnering closely with Global Procurement and GDM vendor management.
Independently determine actions / make decisions quickly based on BMS' book of work with a focus INDs and IND Maintenance-related publishing activities. Assess requests submitted to ensure both data and regulatory accuracy before being submitted to the vendor for publishing. Monitor metrics to ensure quality and on-time are met. Determine turnaround times for certain deliverables (based on circumstances). Manage escalations and other daily workflow related challenges; communications with various stakeholders and management and collaborate and determine best next steps. Identify upstream process breakdowns impacting publishing, involvement in associated issue resolution. Ongoing monitoring and management of key stakeholders is a key part of this role.
Assess and partner with non-BMS entities to help support their needs associated with publishing (e.g. IMD and PRA).
Demonstrated ability to organize/prioritize tasks. Ability to interact with all levels of the organization in a professional manner. Ability to negotiate to acceptable outcomes and ability to influence others. eCTD publishing expertise, global Regulatory electronic requirements knowledge associated with submission publishing. Experience working with external publishing service providers and understanding contractual language and how that relates to execution of work. Demonstrated ability to facilitate issue resolution and conflict management.
BA/BS degree in science / technology field; 3 years relevant regulatory / submissions experience