Associate Director Worldwide Patient Safety Innovation

Profile

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Summary

Reporting into the Sr. Director, Innovation, the Associate Director, Innovation is a member of the Innovation group, a sub-function within Business Capabilities and Innovation (BCI); a division of Worldwide Patient Safety (WWPS).

The Associate Director, contributes to the ongoing development, implementation and successful execution of the business process optimization and automation efforts in line with the overall Innovation Strategy for WWPS; a strategic plan to enhance data driven decision making and adoption of technologies such as cognitive computing and machine learning.

The individual applies a combination of business process, user experience and leadership experience to identify, manage proof of concept projects, use-case development, business analysis, user experience and the activities associated with the automation and AI technologies within WWPS. Utilizing their understanding of business needs and PV/RM information processes, the individual is responsible for leading projects that create and expand knowledge assets and contributes to the continuous improvement and delivery excellence of PV, RM and related data in WWPS information management.

The individual is responsible for promoting a culture of data ownership and governance, innovation, collaboration and experimentation within the WWPS as well as working with the internal BMS groups; managing cross functional communication outside of BCI, and assessing business impact to determine business process optimization opportunities to improve knowledge digitization across WWPS. In addition, the individual supports activities related to the delivery of WWPS data strategies, including input into the production of evidence-based scientific literature, white papers and position papers used to support the application and adoption of new approaches to pharmacovigilance & risk management. The individual will also support the activities around evolving information requirements throughout WWPS.

Core Responsibilities


Provide leadership and support to process automation and other initiatives under the responsibility of the Innovation group.
Support program and project team activities required to implement innovation initiatives.
Management and lead process improvement and innovation initiatives related to knowledge digitization and management across WWPS
Act upon developments in PV and RM landscape; identifying and supporting changes to processes
Provision of support and liaison to WWPS sub-functions in the identification of process improvement opportunities


WWPS Knowledge & Digitization Initiatives


Advance projects for creating and expanding WWPS data strategy and knowledge management
Lead and manage projects related to Ontologies, Lexicons as well as Semantics related to PV & RM
Represent automation and digitization innovation in the Data Governance groups and efforts
Lead initiatives that lead to seamless access to knowledge through use of technologies
Represent BCI as a product owner for projects
Partner with internal and external stakeholders to identify, test and deploy intelligent automation


End-to-end process design, end-user experience development


Manage business activities related to usability testing of new WWPS systems and processes.
Lead teams involved in conceptualization development of future automation tools.
Support of innovation processes and integrate across all relevant groups within WWPS
Partner with Business Capabilities & Innovation team members to lead the design of insight-driven innovative strategies
Define and provide metric reporting and data analysis for innovation initiatives including relevant insights to facilitate decision-making process
Assess and interpret the process impact of automation on processes
Represent WWPS as required on panels at public conferences and workshops related to automation.
Work with BCI work-stream team members to generate opportunities.


Training & Change Management


In partnership with BCI team-members and responsible individuals, develop and execute change management and change readiness assessments and strategies pertaining to data and knowledge management
Support Stakeholder analysis and mapping, identifying potential impacts/risks
Manage and support activities related to design and implementation of organization and job impact analysis
Support, plan and manage execution of activities related to organizational change management and end user readiness as required
Support, lead & manage efforts related to communication and education of the user community on system progress, objectives, and requirements; and develop means to evaluate and ensure organizational readiness for knowledge management initiatives
Identify and anticipate organizational challenges and/or resistance; contribute to the development of risk mitigation and change management plans
Contribute to efforts to build change leadership knowledge and capabilities across WWPS
Plan and Support activities to plan, design, and execute end-user training strategies related to knowledge management projects
Work with BCI group team members to ensure new tools and technologies are appropriately communicated and effectively incorporated into end user training content
Support evaluation of instructional approaches for system end-user training
Conduct and support train-the-trainer workshops as appropriate
Support the review of end-user training materials, job aids and other materials for consistency and relevance in relation to agreed-upon training objectives


Business Process Optimization


Support efforts for 'Use case' development to identify and capitalize on business process opportunities.
Provide on-going communication of all assigned deliverables.
Identify and highlight risks, issues, challenges, obstacles and successes.
Share automation and integration best practices across BCI to maximize effectiveness.
Propose future directions using innovative techniques derived from insights and understanding of process functioning
Identify and evaluate opportunities for Business Process Optimization


Decision Making Authority


Development of recommendations for technology Proof-of-Concept projects
Development of recommendations for technology deployments
Decisions related to the end-to-end process design and end-user experience
Training and End-User change management strategy for all aspects of automation and knowledge management initiatives
Decisions within Innovation group that contribute to overall improvement of data strategy and automation.
Decisions related to Innovation group inspection readiness and risk mitigation strategies


KNOWLEDGE, COMPETENCIES & SKILLS

Learning Skills


Ability to engage in continuous learning and application of learned knowledge
Ability to quickly learn new technologies to be able to apply it in emerging needs as needed
Ability to learn, adopt and apply new processes (including human factor design)


Communication Skills


Ability to convey ideas and facts orally using language the audience will best understand.
Ability to convey ideas and facts in writing using language the reader will best understand
Ability to grasp the meaning of information written in English, and apply it to work situations
Ability to understand and learn from what others say


Personal Effectiveness


Takes personal responsibility for the quality and timeliness of work, and achieves results with little oversight
Ability to adapt to changing business needs, conditions, and work responsibilities
Diligence in attending to details and pursues quality in accomplishing tasks
Ability to build and maintain customer satisfaction with the work products and services offered across safety operations
Demonstrates consistency honesty and professionalism in all interactions
Strong focus on results and desired outcomes
Ability to manage time, priorities, and resources to achieve goals
Ability to maintain composure in highly stressful or adverse situations
Demonstrates diplomacy and handles challenging or tense interpersonal situations


Interpersonal Skills


Ability to build constructive working relationships characterized by a high level of acceptance, cooperation, and mutual respect
Ability to promote cooperation and commitment within a team to achieve goals and deliverables.


Job Family

The Associate Director, WWPS Innovation demonstrates advanced level knowledge of the conduct of Pharmacovigilance or Risk Management globally. The individual is considered a Subject Matter Expert and routinely demonstrates the following competencies;

Operational Leadership


Promotes and practices effective pro-active decision-making, ensuring timely coordination and dissemination of information
Supports Data Governance within WWPS
Promotes visibility of data standards as well as metrics around Data Governance
Incorporates ethical standards of practice as the basis of all interactions across the WWPS and external stakeholders such as Regulatory Authorities,
Ability to develop and implement processes and automation to support the conduct of pharmacovigilance & risk management
Promotes and ensures cross-functional team collaborations and interdepartmental standards and business practices
Attends and supports program team, departmental and organizational meetings
Advocates for individual, team and organizational learning opportunities


Information Management, Analytical & Assessment Skills


Advanced knowledge of taxonomies, ontologies and other knowledge management constructs.
Understanding of data steward role and data management initiatives.
Knowledge and application of MedDRA
Understanding and application of dictionaries within multiple processes in the area of drug safety.
Knowledge and application of commercial coding dictionaries (MedDRA, WHO Drug)
Advanced knowledge to integrate inhouse and external datasets (EMR, OMOP, RWE, FAERS, Vigibase)


Knowledge of Drug Safety Sciences


Ability to describe lessons learned from prominent events in the history of drug safety and application to the current field
Incorporates drug safety regulations and guidance documents into decision making, departmental infrastructure, standard operations, and metrics tracking.
Provides feedback to regulators on draft regulations and draft guidance documents.
Provides training on drug safety regulations, terminology and guidance documents.
Ability to apply use of medical terminology, pharmacology, or clinical background/experience to the field of drug safety.
Advanced knowledge of the cycle of drug development.
Good knowledge of risk/benefit analysis and practical application.
Knowledge and application of safety standards to writing of individual case safety report (ICSR) case narratives or safety sections of clinical study reports, annual and bi-annual safety reports, investigator brochures, and integrated summaries of safety.


Quality& Compliance / Analytics & Process Improvement


Good understanding of the need for data accuracy, completeness, consistency and integrity.
Appreciation of the link between medical services, quality assurance, customer service and drug safety
Understanding of the application of techniques and tools for process improvement
Ability to lead complex, strategic projects (cross-functional, cross Business Unit/Shared Service Unit)
Understanding of statistical techniques for data analysis and data quality
Ability to draw out main messages from data, analysis and research, and identify essential supporting information.


Project Management


Strong organizational and planning skills required including development and execution of project plans.
Must have ability to work independently on multiple tasks
Strong problem analysis and negotiation skills


Training & Development


Knowledge of people, processes and adult learning principles
Ability to analyze training needs and develop new training programs or modify and improve existing programs


Technologies

Working knowledge of:


Pharmacovigilance Systems (i.e. ARISg, agXchange, ARGUS, Empirica Signals, RxLogix)
Microsoft Office Suite
SharePoint 2019 or above
Enterprise Document Management systems (e.g. Documentum or similar)
Reporting Tools


Experience in:


Databases (SQL, Graph, Columnar and noSQL), Data Quality Tools, Data logistics (ETL, ELT)
Integration frameworks (SOA, Restful Services)
RPA (Blue Prism)
Machine Learning/Deep Learning across text and images
UI frameworks (React, Angular, Flask, Spring etc)
Cloud Technologies (AWS, Google), Containers
Big Data Technologies (HDP, Spark, others)


Business Alignment


Aligns the direction, services, and performance of BCI with the rest of the organization
Promotes organizational mission and goals, and shows the way to achieve them.
Promotes Open Communication


Coaching & Mentoring


Enables co-workers to grow and succeed through feedback, instruction, and encouragement.
Helps to attract and develop talent


Fiscal Accountability


Follows fiscal guidelines, regulations, principles, and standards when committing fiscal resources or processing financial transactions


Strategic Vision


Maintains understanding of the big, long-range picture.
Drive Innovation and supports strategy by applying a Global Mindset
Demonstrates adaptability while fostering risk taking and teamwork


Direct Reports


Automation Specialist(s), contractors


Internal/External Partners


Regional & Local Drug Safety Offices including Japan
Regional Corporate partners & WWPS data and technology partners
Process Improvement resources
WWPS Staff


Qualifications & Experience


Life Sciences, Information or similar background (Bachelors, Masters and/or PhD)
Experience/Familiarity with modern technologies (e.g. machine learning, NLP, data driven approaches) and their applications preferred
7 years Pharmaceutical/Biotechnology
4 Knowledge of semantic technologies such as taxonomies, ontologies, lexicons
3 years Drug Safety/Pharmacovigilance experience
2 years Data Governance experience


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1527680_EN

Updated: 2020-07-21 00:00:00.000 UTC

Location: Summit,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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