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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.

Job Description

  • 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

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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.

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