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Project Manager - Agile/Scrum and Kanban, Regulatory functions, CTD, eCTD

Company: Software Management Consultants, Inc.
Location: Thousand Oaks
Posted on: March 21, 2020

Job Description:

Job Description SMCI is seeking a Sr. Project Manager initially focus on incremental improvements of the current process and tooling for authoring in close cooperation with the Regulatory CMC function, as well as help the team to conduct an assessment of existing authoring solutions tools in the market which could satisfy our requirements this aspect will also provide opportunities for business analysis. Role Responsibilities Develop understanding of Regulatory submission authoring, the current way of Regulatory authoring in client (eCTD Module 2 and 3), support requirements analysis for short term improvements, active involvement in the remediation of current gaps and inefficiencies. Manage the evaluation of new document authoring solutions based on business requirements and client's vision of structured content management. Coordinate and lead a large strategic project using Agile methodologies, could include Scrum Master responsibilities leading the team through user-story creation, backlog grooming, story estimation, sprint execution, sprint retrospectives, and all other aspects of running an Agile project. Cooperate with end-users to identify, document, and lead user acceptance tests for IT solutions using Agile approaches such as user-stories and backlog grooming. Work with the project leadership to prepare monthly dashboards, run business-sponsor meetings, and project review presentations. Work with scientists, software engineers, and system administrators to provide solutions to contribute to client s efficiency. Basic Qualifications Master's degree and 7 years of Information Systems experience OR Bachelor's degree and 10 years of Information Systems experience Preferred Qualifications Proficient in leading teams developing software using AgileScrum and Kanban methodologies. Must include actual experience conducting backlog grooming, sprint planning, sprint retrospectives, and scrum meetings. Experienced in dealing with software vendors including assessments of software solutions against defined business requirements. Having a track record of delivering software development projects (either as Sr. Project Leader or Sr. Software Architect). Experienced in working in a similar role in a life sciences environment with exposure to Regulatory Research Development functions and processes. Familiar with Regulatory filing teams, submission standards (CTD, eCTD), and document authoring and management processes. Understand state of the art (big) data methodologies on AWS (enterprise data lake, enterprise data fabric, databases, etc.) is a plus. Experienced working with business users to write and prioritize requirements represented as user-stories. Experienced preparing project reviews and providing executive-level project summaries. Excellent technical, analytical, and problem-solving skills Excellent project management, meeting facilitation, negotiation, and planning skills Results oriented with strong consistency to meeting delivery timelines Excellent verbal, written, and interpersonal communication skills, including the ability to set the context and present on complex subjects in clear and concise manner High learning agility, driven by innovation! Able to master new technologies and processes with minimal support Required Skills AgileScrum and Kanban Regulatory functions CTD eCTD. Don't hesitate! Submit your resume today. SMCI is an EEO employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, national origin, disability, age, genetic information, marital status, military, and veteran status. Members of minority groups, Vietnam Era Veterans and individuals with mental or physical disabilities are encouraged to contact us regarding employment opportunities. In addition, in order to support the provision of business to minority-owned and Women-owned businesses (MWBE), such MWBE are encouraged to contact us regarding subcontracting business opportunities with our firm. (No third parties, please) (H1 sponsorship currently unavailable) (Local candidates only, please)

Keywords: Software Management Consultants, Inc., Thousand Oaks , Project Manager - Agile/Scrum and Kanban, Regulatory functions, CTD, eCTD, IT / Software / Systems , Thousand Oaks, California

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