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Actual title: Instructional Designer/Training
Summary of Responsibilities
As a member of the Development Operations Team, contribute to and support all training activities for all supported-software platforms, applications, and tools. Deliver regular and consistent training sessions for the global user base as needed. Develop and revise relevant training materials as needed for new systems and system changes. Represent Development Operations from a training perspective on cross-functional projects and in the development of new business processes. Provide training support in electronic information management and submission tools and strategies to assist other members of Development Operations in submission responsibilities. Contribute to Tier 1* and Tier 2† activities, and participate on Tier 3‡ system implementation activities with a focus on training delivery. Work across geographic regions to provide support in conjunction with other members of the Development Operations Team.
• Works with the internal training team within Development Operations to develop and deliver training; providing analysis and documentation support as needed for Development Operation and peripheral systems.
• Can serve as a system Business Administrator and provide support if needed.
• Work collaboratively with multi-site team members and cross-functional department representatives, assist in documenting new policies, standards and procedures for automated processes within Development Operations, including but not limited to Regulatory Document Management System (RDMS), Submission Publishing System (SPS), Submission Information Management System (SIMS), and Submission Management System (SMS).
Development Operations experience preferred, optimally within a start-up and/or small biotech company and a large pharmaceutical/healthcare company, with direct experience in systems training, implementation and support.
• Must be able to effectively design SCORM based eLearning modules using Articulate Storyline.
• Excellent presentation skills required, candidate must demonstrate the ability to present and deliver instructor-led classroom sessions in person and via WebEx.
• Must be able to master new software and technical skills and apply them to projects as the industry, team, and the company evolve.
• Must be able to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy customers.
• Must be able to work effectively within an environment that has quickly changing processes, priorities, and deadlines.
• Requires an in-depth understanding of standard software such as MS Word, Adobe Acrobat and standard Office tools.
• Demonstrated in-depth knowledge of eCTD, and familiarity with pharmaceutical development and Regulatory global submissions preferred.
• Strong computer skill set and working knowledge of electronic submissions software and requirements preferred.
• An in-depth familiarity with global Regulatory submissions and document management.
• Detail oriented with strong trouble-shooting\problem\task analysis skills.
• Computer system validation/change management a plus.
• Graphic and UX design skills preferred.
• Exceptional interpersonal skills, including teamwork, and facilitation.
• Experience working with cross-functional teams.
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