BD (Becton, Dickinson and Company) Senior Manager, Global Regulatory Processes in San Diego, California
Job Description SummaryIn this newly created position reporting to the Regulatory Operations Systems Director, the Senior Manager of Global Processes will play a lead role in building and refining BD's regulatory information management and document management system processes. The Sr. Manager, RA Processes guides a global/local team of regulatory professionals and other functional team members by overseeing the end to end delivery of dedicated improved process framework.
Regulatory system adoption and usage
Ensuring that the Process and Governance Structure is fit-for-purpose
Defining the Business Cases for the various RA processes
Ownership of processes, implementation and maintenance for Global RA Processes.
Ensuring there is optimal fit between people, process, technology (tool) and steering
Taking a ‘helicopter view’, overseeing and ensuring integration of new processes and linked with technology.
Lead and communicate changes to the Process and Governance structures
Initiate improvements in the process, steering mechanisms, and people.
Review integration issues between the various processes
Provide IT support, business analysis, validation expertise, technical writing, project management learning development and training for document management and regulatory systems.
Plan and manage complex projects and prioritize workload
Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with BD and external standards
Maintain appropriate communication within the RA function, QA, R&D, and other functions primarily at the project team level
Assess impact of new technology and processes and provide feedback.
Provide support for all aspects of regulatory submissions including related technology, validation, document management and best business practices, not only for the regulatory arena but for all departments (clinical, quality, nonclinical) that provide documents and data to regulatory submissions.
Set team, group, or service objectives to assure they align with the Regulatory strategy
Provide technical and strategic input for regulatory decisions
May manage budget
Strong leadership and influence management skills and the ability to function effectively in large matrix organizations.
Excellent analytical and problem solving skills
Sound working knowledge of the Global regulatory environment
Strong coaching and mentoring skills
Ability to effectively communicate complex issues and programs to all levels of the organization.
Experience and knowledge of PC/database skills
Experience and knowledge of document management systems
Leadership:Proven ability to earn the trust of leaders within the organization, including senior leadersProven ability to mobilize, motivate and direct a matrix team towards a common vision and common set of objectivesProven ability to resolve conflict (striving for win-win outcomes)Proven ability to deliver tough messages in a professional mannerProven ability to act independently and to execute with limited information and ambiguity
Education and/or Experience:
Deep understanding of interpreting business processes into user requirements and system capabilities
Knowledge of software development lifecycle for validated systems
Lean six sigma
Knowledge and experience with enterprise document management systems and functionality (DMS).
Bachelor degree in science or health related discipline or over 15 years of directly related experience in relevant Regulatory Systems ownership/management or IT experience.
Strong interpersonal skills with the ability to influence others in a positive and effective manner
Ability to work in a team environment
Working knowledge of Medical Device and IVD development and approval process and life cycle maintenance
Excellent communication skills; both oral and written
This position is a temporary assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy. This position will support BD & BARD integration efforts and is anticipated to last for an estimated two years
Primary Work LocationUSA CA - San Diego TC Bldg C&D
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.