Training and Education Lead, Associate Director / Sr. Manager

ROLE SUMMARY Provides strong technical expertise and program leadership required for the development and implementation of global training and educational projects in support of clinical research, medical, pharmacovigilance, regulatory, and quality.  This position requires extensive learning development, instructional design and program management skills as well as the ability to work with senior stakeholders to establish strategy for training and educational programs.  Prior experience with the design, development and implementation of quality global educational programs, advanced learning program management, technical and communication skills are required.  Leads cross-functional teams on key programs to align with global business objectives to meet critical needs across the organization.  Experience working with senior leadership to direct and manage the overall educational program and training development, deployment and maintenance process as needed.  In collaboration with business stakeholders, define educational strategies to ensure that customers are provided the necessary training to perform the requirements of the role.  Ensures that the training design incorporates diverse and innovative methodologies to meet training standards and quality. Manage and deliver instructor-led training courses as identified.  This position leads training and education efforts focused in clinical data management, statistics, programming including programs related to applications and systems. RESPONSIBILITIES As the educational program lead for projects, works with stakeholders to establish support levels, strategy, and operational educational programs for departmental, Business Units (BUs) and enterprise level training initiatives.  Responsibilities include: Managing deliverables according to endorsed plans and timelines across multi-functional teams.  Managing development of courseware strategy including course design, development and deployment.  Partnering with associated business line and Subject Matter Experts (SMEs) to proactively identify training needs and development and deployment of training programs. Developing processes, as needed, and monitor activities related to compliance oversight of training programs. Ensuring programs and projects are evaluated for effectiveness and customer satisfaction and that feedback is shared and utilized as part of the continuous improvement process. Ensuring course assignments are appropriate through interaction with governance bodies and partner organizations. Development of metrics and performance measures, reporting and analysis to meet business needs, and regulatory requirements Budget management; develop and manage budget for training projects. Ensuring compliance to training and education regulatory requirements and consistent implementation of best practices, standards, and training globally to support inspection readiness Mentoring colleagues or peers and serve as a role model BASIC QUALIFICATIONS Education and Work Experience Bachelor's degree and minimum 7 years in pharmaceutical industry with focus on pharmacovigilance, regulatory or clinical OR Master's degree and minimum 5 years in pharmaceutical industry with focus on pharmacovigilance, regulatory or clinical OR Ph.D./PharmD/ MD and minimum 3 years in pharmaceutical industry with focus on pharmacovigilance, regulatory or clinical. Other Demonstrated expertise of learning principles, instructional design as well as project management required. Advanced business knowledge of Clinical Research & Development, Pharmacovigilance, and/or Regulatory in the pharmaceutical industry. Demonstrated ability to manage multiple, highly complex projects concurrently. Prior experience in monitoring adherence to compliance-based training programs. Demonstrated ability to influence and negotiate effectively /  Experience working globally with organizations/teams/individuals Ability to implement large-scale change in complex, matrix organizations Required Computer Experience: LMS administration, Microsoft Office (Outlook, OneNote, Excel, Word, PowerPoint,), Adobe and survey tools. 4718114
Salary Range: NA
Minimum Qualification
8 - 10 years

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