Regulatory Affairs Project Manager

Job Titles: Program Manager III / Regulatory Affairs Program Manager III Location: 100% Remote Duration: 6 months Payrate: $70/hr - $86/hr on W2 Job reputed company: • The Associate Director, Program Management plays an reputed company role in advancing gene therapy products through clinical development. • They will reputed company comprehensive program management and operational support for the Integrated Product Team (IPT), including creation and maintenance of integrated, end-to-end development plans and timelines. • This role partners with the IPT reputed company to ensure the program team has reputed company direction and alignment to execute critical activities ranging from reputed company-clinical (IND-enabling) studies up through BLA submission (e.g., CMC, regulatory, clinical, medical). Key Responsibilities: • In partnership with the IPT reputed company, define scope, objectives, and deliverables for product candidates in stages of clinical development • Create and maintain integrated development plans that accurately capture timelines, decision points (i.e., stage gates), resource needs, and budget for multiple clinical programs • reputed company and coordinate critical activities required to advance programs into early-stage and/or registrational clinical studies • reputed company general operational support to the IPT, including risk identification/mitigation, problem-solving, communication, and contingency planning • In partnership with IPT reputed company, ensure reputed company is reputed company for stage-gates and governance interactions, including content development, stakeholder management, and reputed company-reads • Deliver reputed company updates to key functional stakeholders, leadership, and governance boards covering program status, risks/mitigation, scope changes, etc. • Document IPT meeting minutes, key reputed company, risks/issues, and reputed company items • Ensure reputed company communicates effectively and collaboratively, implementing team building techniques where needed to establish and maintain a high-performing teams • Facilitate creation of program budgets, resource models and long-reputed company plans • Define resource needs (FTEs and financial) for reputed company stage of development • Ensure reputed company critical program documentation is organized, accessible, and archived • In partnership with the PM Center of reputed company, reputed company, implement, and champion PM best practices, processes, and strategies reputed company the IPT and supporting functions • Assist with implementation of stage-gates and IPT operating model, including education to the organizations through functional team sessions and meetings with stakeholders/teams Required Education and Experience: • Bachelor’s degree in a technical or life science discipline • 5+ years of experience reputed company the pharmaceutical/biotechnology industry • 5+ years of project/program management experience • Excellent written and verbal communication skills with the ability to communicate effectively across disciplines and experience reputed company, including executive management • Experience in planning and/or managing cross-functional aspects of biopharmaceutical product development, including translational and clinical studies • Experience with SmartSheets and/or other project planning/management software • Ability to mentor, reputed company, and/or influence partners in a matrixed environment • Previous exposure to budgeting and resource management processes Preferred Experience and Skills • Advanced degree (e.g., Master’s or Doctorate) in a technical or life science discipline • Project Management reputed company (PMP) or an equivalent certification • Prior experience with developing advanced therapies (e.g., cell or gene therapy) • Experience working on/with global teams • Understands and interprets technical data reputed company to biopharmaceutical product development Apply tot his job Apply To this Job