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Global Regulatory Operations Intelligence Manager

Company: Jazz Pharma
Location: Palo Alto
Posted on: May 4, 2021

Job Description:

Overview:Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.Responsibilities:With minimal oversight, the Manager, Regulatory Intelligence will manage the compilation of accurate and timely intelligence and manage a cross-functional process that will result in an impact assessment to Jazz and then drive the implementation of change actions based on the analysis of intelligence. This will include using and developing appropriate information and intelligence analysis methodologies and processes to support delivery of the objectives that align with Jazz priorities. The Manager, Regulatory Intelligence will regularly prepare and present regulatory intelligence across departments and to senior management. This role will also be a key a contributor to the design, development, and implementation of a Regulatory Intelligence platform and associated business processes. Essential Functions

  • Research, collect, organize and maintain files on regional and global regulatory intelligence and other related information for all markets where Jazz has a presence or is planning a presence.
  • Apply industry standard methodologies and tools to conduct intelligence analysis and profiling to identify emerging compliance risks, trends, and opportunities.
  • Deliver advice and contribute to effective strategy development concerning regulatory submissions, approval pathways and compliance activities that affect Jazz assets.
  • Initiate electronic workflow to route newly identified intelligence to appropriate functions to thoroughly assess potential impact to Jazz and assign actions to ensure a closed looped mechanism for identifying, assessing, and taking action on emerging intelligence.
  • Initiate change controls and act as a project manager to ensure implementation of identified actions.
  • Contribute expertise to a cross-functional team that defines and oversees the standardization and implementation of systems/processes to monitor the regulatory environment for changes that may have an impact on Jazz's projects, objectives, and products.
  • Facilitate and lead presentations, discussions and forums up to senior management level, which provide intelligence and analysis on emerging trends and potential risks.
  • Promote an intelligence culture that supports a targeted approach to compliance.
  • Engage and develop tactical/operational partnerships to enhance the building and sharing of intelligence across Jazz R&D and Commercial.
  • Ensure alignment with other Regulatory Intelligence initiatives across Jazz, primarily Pharmacovigilance.
  • Develop formal process for submitting Jazz comments to agency requests for input to proposed rule changes, legislation, and guidance.
  • Author, review, and approve applicable SOPs, Work Instructions, Best Practices, Policies, and Internal Guidance.Education, Behavioral Competencies, and Skills:
    • Bachelor's Degree is required. Science, Engineering, Computer Science or business-related field preferred.
    • Knowledge and a sound understanding of regulatory and compliance functions and purpose.
    • Sound knowledge of industry standard sources, tools and methodologies for collecting and organizing literature, news and intelligence; preferably Cortellis, InfoDesk, StoryTeller, Embase, PubMed, and RightFind.
    • Good level of competence in the use of specialized intelligence software.
    • High level of critical reasoning skills and a well-developed intuition about appropriate approaches, and risks.
    • Ability to coordinate information from various internal and external disciplines.
    • Proven ability to communicate clearly and present key information objectively; demonstrated ability to clearly communicate/ prepare presentations for management.
    • Analytical and Problem-Solving Skills - ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem. Excellent ability to understand complex issues and propose creative and achievable solutions.
    • Leadership Skills - ability to lead and motivate team members, without direct line management responsibility. Develops, uses and shares knowledge and uses strong interpersonal skills to influence and guide others towards the accomplishment of Jazz's goals and objectives
    • Strategic Approach - identify, create, and implement processes for Regulatory Planning that satisfy business objects of Jazz globally.Presentation skills - create and deliver presentations with appropriate messaging and focused recommendations. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

Keywords: Jazz Pharma, Palo Alto , Global Regulatory Operations Intelligence Manager, Executive , Palo Alto, California

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