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.
The Submission Publishing Workflow Manager manages and coordinates the workflows that support the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities.
- Manages the workflow of all document and submission publishing requests (all submission formats-- IND/NDA/BLA/MAA, etc.) between BMS and our service providers; works closely with both service providers and BMS teams to ensure daily awareness of priorities for document and submission publishing.
- Builds, maintains and monitors systems and processes to ensure that quality and on-time metrics are available and met by our multiple service providers.
- Develop and implement consistent processes to ensure 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.
- Drives 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.
- 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, 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. Understands contractual obligations and ensure BMs and service providers meet contractual obligations by partnering closely with Global Procurement and GDM vendor management.
- Independently determines actions / make decisions quickly based on BMS' book of work for publishing activities.
- Assesses requests submitted to ensure both data and regulatory accuracy before being submitted to the vendor for publishing.
- Monitors metrics to ensure quality and on-time are met; determines turnaround times for certain deliverables (based on circumstances).
- Manage escalations and other daily workflow related challenges; communicates with various stakeholders and management and collaborate and determine best next steps.
- Identifies upstream process breakdowns impacting publishing, involvement in associated issue resolution; ongoing monitoring and management of key stakeholders is a key part of this role.
- Assesses and partners with non-BMS entities to help support their needs associated with publishing.
- BA/BS degree, science / technology field preferred or 10+ years of 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:
- Strong working knowledge of publishing tools and regulatory submission procedures.
- 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 influence others.
- Demonstrated ability to facilitate issue resolution and conflict management.
- Experience working with external publishing service providers and understanding contractual language and how that relates to execution of work
- US military experience will be considered towards industry experience requirements