Job Description

Title: Senior Manager- Document Management Location: Hyderabad Position Summary : Lead a team of Documentation Specialists and provide training, mentorship and strategic direction to deliver protocols, periodic reports (IBs, DSURs), clinical study reports, and eCTD documents at a sustainable speed while maintaining document quality and compliance with electronic submission requirements. Key Competencies: Thorough understanding of requirements for major regulatory submission documents. In depth knowledge in managing the production and process flow of regulatory documents. Strong ability to provide strategic direction and subject matter expertise in the planning and timely submission of protocols, clinical study reports, periodic reports (IBs, DSURs) and eCTD document for all assets in early, full/late development. For each document type, establish and maintain documentation standards, templates and best work practices that are consistent with internal and external guidelines for regulatory submissions Establish partnership with other client functional areas to maintain fully integrated and standardized processes that support regulatory documentation in order to meet client R&D objectives and priorities Demonstrated experience in training, mentoring and professional development of junior colleagues in a group. Subject matter expertise in desktop applications, word template macros, model documents and submission readiness formatting for creation of eCTD compliant regulatory documents. Subject matter expertise in Acrobat and ISI toolbox usage for creation of complex PDF compilation and remediation of PDF documents for eCTD compliance. Subject matter expertise in the document management system for assembly and management of complex regulatory documents. Deep understanding of document publishing processes across GSRD document types Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills Effective interpersonal skills to work well in a matrix team environment and with colleagues at all levels in the organization A proven record in managing a large group/project team with solid behaviors in cross-functional collaboration and communication Experience in working in a rapidly changing environment where decisiveness, adaptability, and communication are critical to success. Lead and provide strategic direction and external authors for CARA structure assembly, submission readiness and document publishing of all submission level documents Lead and provide strategic direction to cross functional business partners in defining submission ready requirements for ICH non-data driven appendices and externally authored documents Provide strategic direction and independently coordinate, compile and/or author select submission document types ensuring integration of scientific and regulatory input from team members Lead training for new internal and external staff.

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