Associate Director, Submission Publishing, Global Dossier Management
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, Global Dossier Management is responsible for:
- Proactively identifies and addresses complex 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 when necessary, with the GRS liaison to provide submission publishing subject matter expertise to ensure eCTD compliance.
- Interacts frequently with our key vendors to ensure continuous improvement, defining and implement best practices and troubleshooting complicated technical issues and processes for BMS Submission Management team.
- Advises all internal and external project team members on frequently evolving e-submission requirements, strategy and associated industry best practices.
- Lead internal submission publishing team, defines internal processes to oversee fully outsourced services and manages vendor relationship specific to submission publishing.
- Provide drug development and technical knowledge to functional area contributors on electronic regulatory submission requirements and publishing processes.
- 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.
- 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)
- Regulatory Records Management
- Regulatory Knowledge of Global Filing Requirements
- Rest of World Submission Support (including NeES, ACTD etc.)
- Knowledge of how to independently build entire complex submissions.
- Oversight and management of team workflow to support the fully outsourced service. Coaches and energizes others on complex technical, regulatory and departmental processes. 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.
- Possesses the ability to troubleshoot and resolves complex issues. Implements procedural changes as appropriate. Disseminates information to others in functional role.
- Understanding of change management concepts.
- Responsible to ensure their team receives the appropriate training, mentoring and coaching; proactive identification of future training needs.
- Participates in development discussions with employees in coordination with GDM Executive Director.
- Proactively identifies and manages employee issues/problems. Initiates action plans where applicable. Is able to provide both positive and negative feedback constructively.
- Lead or coordinate the GDM part of Initiatives for Divestitures and Transfers of Products.
- Allocate resources for annual review of SOPs/WIs. Allocate resources for technical projects/initiatives.
- 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.
- 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.
- Provide support to other managers of people within the department. Share experiences and provide feedback when requested with regard to people management experiences.
- Bachelor's degree in technical subject with ≥10 years of industry experience
- At least 2 years supervisory experience required.