Senior Manager, Integrated Systems Documentation Management Technology
Employment Type: Full-Time
Industry: Non-Executive Management
Your tasks and responsibilities The primary responsibilities of this role, Senior Manager, Integrated Systems Documentation Management Technology, are to: Act as Electronic Records/Data Manager, proactively identifying RA data/ document management strategies and needs, ensuring regulatory documents are properly received, stored, tracked and retrievable according to appropriate industry standards and regulatory guidelines covering but not limited to internal SOPs, OIs, ICH guidelines, HA regulations and legal standards; Represent DM on project development teams as it pertains to eDMS procedural and technical regulatory aspects of such projects. This includes, but is not limited to ensuring all relevant guidelines and standards are adhered to and aligned with all other global DM; Ensure adherence to RA aspects of any eDMS system end to end, e.g. development, validation, implementation, maintenance as necessary; Implement RA electronic document software system business administrative responsibilities; user accounts, access control/permissions, workflow implementation, templates and end user training; Monitor and implements evolving new health authority regulations requiring interactions with Submissions, RA GRSs and all R&D functions contributing to submission relevant documents; Provide input to service provider assessments and interacts with service vendors with regards to new applications selections; Support and trains R&D colleagues, system managers, and RA Process Managers supporting electronic RA information management processes and Technologies; Ensures critical, effective and proper coordination of regulatory documentation in coordination of regulatory requirements varying from country to country and having numerous worldwide regulatory affiliates. Who you are Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following: Required Qualifications: Minimum of a Bachelor degree is required plus 8+ years of progressively increasing responsibilities and relevant experience or Master's degree and 5+ years of progressively increasing responsibilities and relevant experience or PhD and 4+ years of progressively increasing responsibilities and relevant experience; Proven relevant experience may be met via a combination of electronic data/document management, project management, computer systems support, eDMS, Regulatory Affairs, or eDiscovery; Extensive experience of eCTD/NeeS regulatory requirements; Proven experience with document management systems; Experience evaluating and implementing new electronic software; Experience training employees on IT-based systems; Proven history of training and motivating teams; Customer and team orientation; Proficiency in MS Office: Word, Excel, PowerPoint; Ability to communicate effectively in English both verbally and in writing; Ability to analyze and solve problems; Ability to prioritize work and support requests.Salary Range: NAMinimum Qualification8 - 10 years
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