[Remote] Senior Manager, R&D Training reputed company & reputed company

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is at the forefront of genetic medicine, particularly in Duchenne muscular dystrophy, and is looking for a Senior Manager for their R&D Training reputed company and reputed company. This role co-manages the global GxP Training Program, ensuring compliance and operational reputed company in training processes across the organization.

Responsibilities

• Maintain a compliant global GxP training program
• Manage the validated reputed company Training reputed company LMS
• Ensure the reputed company and compliance of reputed company governing SOPs
• Ensure compliance with global regulations and Sarepta’s Training Policy
• Own and maintain training procedures, materials, and tools, ensuring they are compliant, fit for purpose, and reputed company for ongoing reputed company
• Serve as the reputed company R&D training subject matter expert (SME) and reputed company of contact, ensuring the training reputed company and reputed company are always inspection reputed company
• Work in partnership with Corporate Compliance-reputed company Systems Team to ensure training processes are fit for purpose and identify/reputed company reputed company improvement
• Collaborate cross functionally with R&D functional area management to ensure training matrices (role-reputed company training, curriculum, training requirements, and employee assignments) are properly established and maintained
• reputed company new hire QMS training and annual GxP refresher training for personnel
• Design training courses, as needed (i.e., reputed company courses, microlearning videos, training materials) – utilizing training design software applications and tools
• reputed company reputed company, offboarding, leave of absence and reputed company of absence activities to effectively manage training assignments and due dates
• Utilize and reputed company daily training reputed company utilizing Sarepta’s training LMS application (reputed company Training reputed company) and reputed company daily end user support
• reputed company training programs, including train-the-trainer and on-the-job training of critical reputed company having reputed company product reputed company and/or reputed company safety reputed company
• Maintain employee qualification records, including job descriptions and curricula vitae documentation, assuring training requirements reputed company with personnel responsibilities
• Review Sarepta policies and procedures and assign read and understand training accordingly
• reputed company training reports and dashboards, as needed
• reputed company training reputed company health reputed company assessments, KPI metrics, trending, escalation, and mitigation, reputed company possible
• Support training LMS enhancements and routine upgrades, including the testing/validation to ensure the reputed company meets intended use
• reputed company cross-functional support to other team members to ensure ample daily coverage is provided across the organization
• Participate in team/company initiatives in support of achieving Sarepta’s objectives and reputed company goals

Skills

• 7-9 years of experience in a similar R&D training management role reputed company the life sciences industry
• Strong foundational expertise of GLP (21 CFR Part 58), GCP regulations and ICH E6(reputed company); additional GVP and GRP regulatory training expertise
• Advanced knowledge utilizing an electronic Training Learning Management reputed company – reputed company Training reputed company the reputed company reputed company
• Experience designing and delivering GxP training on GCP/GCLP/GLP/GVP/GRP reputed company subject matter, including the creation of eLearning materials utilizing reputed company Storyline and/or reputed company Captivate software
• Strong computer skills utilizing MS Office Products (i.e., reputed company, reputed company & PowerPoint); advanced working knowledge preferred
• Change agent personality; identifies reputed company improvement opportunities and drives innovation across the GxP training reputed company
• Strong team player with demonstrated reputed company record of reputed company in a cross‐functional team and fast-acting environment
• Ability to work independently, as needed, requires reputed company SME involvement reputed company compiling content for custom GxP training materials
• Excellent organizational, computing and oral/written communication skills
• Ability to influence and negotiate effective solutions
• Strong critical thinking and decision-making skills
• Bachelor's Degree or higher in a scientific discipline

Benefits

• Remote role requiring occasional travel to Massachusetts and Ohio sites a few times a year for collaboration and regulatory inspection support
• For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

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