Director Regulatory Informatics And Analytics - Takeda (Lawrence)
: $146,240.00 - $146,240.00 /year *
: Executive Management
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Director Regulatory Informatics And Analytics - TakedaACCOUNTABILITIES Serves as the lead business owner of Regulatory information and associated processes and systems. Ensures information and data standards are aligned with Takeda's strategic business requirements (e.g. MDM, Regulatory strategy, Industry standards, HA expectations) Defines the regulatory informatics strategy, standards, and governance. Represents GRA in Takeda forums/initiatives regarding the analysis, governance, and use of Regulatory information ACCOUNTABILITIES (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 10 bulleted task statements should be identified). Serves as the lead business owner of Regulatory information and associated processes and systems. Ensures information and data standards are aligned with Takeda's strategic business requirements (e.g. MDM, Regulatory strategy, Industry standards, HA expectations) Defines the regulatory informatics strategy, standards, and governance. Represents GRA in Takeda forums/initiatives regarding the analysis, governance, and use of Regulatory information Represents Takeda at industry forums regarding information management and standards and is viewed internally/externally as an expert in the field. Demonstrates high level of leadership and expert understanding of global RA information/data set regulations and guidelines by applying interpersonal skills and expert RA knowledge to address and overcome challenges that arise Successfully communicates and negotiates with international Health Authorities as necessary, directly or indirectly Oversees day-to-day GRA informatics initiatives (integration, acquisitions/divestatures, IDMP,xEVMPD, SPOR, MDM). Lead and define the development and execution of strategic and change management initiatives. Oversees external vendor for publishing and management of regulatory submissions, including the development and oversight of robust all regulatory submission KPIs, ensuring vendor readiness for global submission Health Authority requirement, oversight of vendor activities for RIM system maintenance. Accountability and oversight for internal publishing and submission management activities Oversees and mentor direct reports, providing leadership and training to support professional development. Responsible for demonstration of Takeda Leadership behaviors. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge) Comprehensive understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc) Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change) Demonstrated ability to work across functions, regions and cultures Functional level leadership with the ability to inspire, motivate and drive results Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing Proven skills as an effective team player who can engender credibility and confidence within and outside the company Ability to distil complex issues and ideas down to simple comprehensible terms Demonstrates leadership presence and confidence Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives. Invests time in helping others to enhance their skills and perform at a higher level Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-soliving) Decision making responsibilities: Provide input to highly complex decisions that impact the functional area Accountable for decision making for designated function Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution Accountable for providing input to and implementing vision and strategy for designated scope Interaction (The span and nature of ones engagement with others when performing ones job, internal and external relationships) Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise. Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taki
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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.