Associate Director, Submission Publishing
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 Associate Director, Submission Publishing manages the operational activities for document and submission dossier publishing and leads the internal submission publishing team. S/he is the primary point of contact and subject matter expert for multiple internal stakeholders, as well as managing submission publishing workflows and general relationship with the vendor.
- Proactively identifies and addresses complex document and submission publishing issues/opportunities by working with upstream functions (GBS, GCO, etc.) and recommending and assisting in implementation of solutions or escalates to appropriate parties for resolution.
- Interacts with the GRS liaison to provide document and submission dossier publishing subject matter expertise to ensure eCTD compliance.
- Interacts frequently with key vendors to ensure continuous improvement, defining and implement best practices and troubleshooting complicated technical issues and processes for the BMS Submission Management team.
- Advises all internal and external project team members on frequently evolving electronic submission requirements, strategy and associated industry best practices.
- Leads internal submission publishing team, defines internal processes to oversee fully outsourced services and manages vendor relationship specific to submission publishing.
- Serves as the primary point of contact with GRS Informatics regarding system and technical issues utilized to support fully outsourced services.
- Serves as the primary point of contact for functional areas such as Labeling, Clinical, Legal, eTMF, Drug Supply, etc. related to GDM processes and fulfilling requests; provides drug development and technical knowledge on electronic regulatory submission requirements and publishing processes.
- Primary point of contact when unique or specialized technical / submission publishing topics arise that need to be addressed with FDA.
- Possesses an in-depth expertise in desktop applications and document management, dossier publishing and publishing systems including effective troubleshooting skills and participates in the development/enhancement of new systems.
- Mastery of applicable Regulatory processes (see list below) including eCTD as well as other departments' procedures (e.g., drug release).
- NDA, BLA, MAA, CMC submissions
- INDs, Amendments
- Annual reports
- Drug shipment (Export waivers)
- Document Management
- Regulatory Records Management
- Regulatory Knowledge of Global Filing Requirements
- Rest of World Submission Support (including NeES, ACTD etc.)
- Oversight and management of team workflow to support the fully outsourced service; coaches and energizes others on complex technical, regulatory and departmental processes and creates and champions novel approaches to existing work processes.
- Implements the goals for workgroup, assist in the creation of and communicates a supporting strategy with clarity, force, and impact to align people, critical resources, management and stakeholders.
- Lead role in developing, coordinating and conducting department technical and process training to department staff and client community.
- Mastery of electronic document and dossier management including a working knowledge of electronic regulatory submission guidelines and requirements; knowledge of how to independently build entire complex submissions.
- Troubleshoots and resolves complex issues and implements procedural changes as appropriate; disseminates information to others in functional role.
- Ensures his/her team receives the appropriate training, mentoring and coaching; proactive identification of future training needs.
- Participates in development discussions with employees in coordination with GDM Director.
- Proactively identifies and manages employee issues/problems; initiates action plans where applicable. Is able to provide both positive and negative feedback constructively.
- Leads or coordinates the GDM part of Initiatives for Divestitures and Transfers of Products.
- Allocates resources for annual review of SOPs/WIs. Allocates resources for technical projects/initiatives.
- Full understanding of all publishing processes and how change in any one part of the process could potentially impact others areas of the processes. Ability to escalate these issues when identified to the correct level and provide suggested solutions.
- Bachelor's degree in science/technology field with 10+ years of Pharma industry experience
- 5 years' supervisory experience; may be combination of supervision of staff and project oversight with matrix team.
- 5+ years of submissions management or similar relevant experience
- HA electronic requirements knowledge associated with document and submission publishing
Ideal Candidates Would Also Have:
- Experience engaging and managing external partnerships
- Ability to create an environment where others will try new approaches and learn from results
- Ability to create opportunities to review the successes and failures of new approaches to capture lessons learned
- Experience in developing and leading change management concepts and programs
- US military experience will be considered towards industry experience requirements