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Project Manager

Posted on Nov 16, 2018 by Bulletproof Documentation, Inc.

San Diego, CA 92101
Research & Development
26 Oct 2018
Annual Salary
Full-Time
As a member of the Bulletproof family, you'll enjoy a culture that values diversity in all things - people, work, experience levels, and much more. We tackle the toughest challenges, produce impactful results, and build solid client relationships along the way - with energy, passion, and fun. If this sounds like a good fit for you, please consider this exciting opportunity with our firm!Position Title:Product Project Manager, Product Portfolio Management The Product Project Manager Position is dedicated to supporting Technical Regulatory Teams ( TRTs) inmanaging programs efficiently and effectively and in executing regulatory activities. This role will beinvolved in all aspects of TRT operations, while maintaining a tight linkage to the PTR Product PortfolioManagement Office ( PMO). The Product Project Manager is an advocate of the PMO, utilizing bestpractice methodologies to support TRTs and providing clear communications to the PMO for assessmentand trending at the portfolio level.This role builds effective relationships with Technical Regulatory Leads ( TRLs), TRT Members, ProductPMO, Technical Development Teams, Technical Product Teams, and other program stakeholder toensure visibility to TRT operations and cross-functional alignment of TRT strategy. The technicalmanager may act as a single point of contact for a TRT, second only to the TRLs, the primaryaccountable leaders of TRTs.JOB DESCRIPTION - primary duties and responsibilities = 623; Support TRTs and TRLs in developing TRT charters, plans, detailed schedules, deliverables lists,status updates, resource requests and program specific communications for individual programsin the regulatory product portfolio including large molecules, small molecules, devices, antibodydrug conjugates. = 623; Provide technical management support to TRTs at any stage of the drug development lifecycle ( i.e. clinical /development, marketing authorization or post-launch marketed phases). = 623; Coordinate and facilitate TRT meetings and all aspects of program information managementensuring robust documentation and communications. = 623; Partner with TRLs and site management, facilitating team interactions and mobilizing teams todeliver successfully on the agreed objectives. = 623; Execute project management activities to support products for global market applications andproduct life-cycle activities. = 623; Support issue-specific multi-product impacting regulatory projects to ensure alignment ofregulatory strategy and compliance across the Biologics and Small Molecule platform. = 623; Ensure regular and meaningful project communications, including dashboards, reports andmetrics, to enable timely information and analyses to key stakeholders and decision makers. = 623; Ensure product information flows between TRT members to ensure transparency, informeddecision making, and optimal alignment of all technical regulatory deliverables. = 623; Maintain linkage between TRT and TDT or TPT ensuring alignment of assumptions andcommunications at all times. = 623; Facilitate regulatory program risk assessment and align with TPM and TDT processes. Develop,execute and report on risk mitigation or issue resolution activities. = 623; Monitor critical path timelines and resources for assigned products using appropriate tools,principles and practices to deliver successfully on time. Collaborate with Program Managers fromcross-functional teams as necessary ( TDT, TPT, RAFT etc.). = 623; Provide support to the Product PMO and to the PTR site management on major departmentaland cross functional initiatives. = 623; Leverage and continuously improve Product PMO business process and program managementmethodologies. = 623; Develop and maintain the PMO resource library ( templates, tools etc.) and improve it based onuse and feedback by the TRTs. = 623; Collaborate with Regulatory Operations and colleagues in PTR and PDR for regulatorysubmissions as needed. = 623; Train junior PTR colleagues in the principles of Project Management and establish simple projectmanagement processes for early stage products. QUALIFICATIONSEducation & Experience = 623; BA/BS in Scientific, Technical, Engineering or Business discipline. = 623; A minimum of 5 years' total work experience with at least 2 or more years' relevant experience inproject management within the pharmaceutical/biotech industry with a sound knowledge of drugdevelopment processes. = 623; Project, Program, or Portfolio Management certification is preferred; Knowledge of Portfolio andProgram Management methodologies, concepts, techniques and tools is required. = 623; Prior experience managing portfolios in a strategic context is a plus. = 623; PMP Certification preferred. = 623; Prior regulatory experience a plus. = 623; Six Sigma or other OE-related certifications a plus.Knowledge/Skills/Competencies = 623; Demonstrates, or has proven abilities to demonstrate PTR and Roche Core Competencies. = 623; Proven abilities to effectively lead, organize and prioritize the work of others. = 623; Strong influencing skills; consistently achieves targeted results without authority and byleveraging his/her expertise, business knowledge, interpersonal skills, organizational savvy andrelationships. = 623; Strong partnering skills; has exceptionally strong and highly effective working relationships withinternal and/or external customers, partners and stakeholders. = 623; Excellent interpersonal and organizational skills, including understanding of key changemanagement concepts and methodologies. = 623; Must work well as member of a diverse team and in a proactive, positive and collaborativemanner; Ability to lead cross-functional teams. = 623; Outstanding project management, planning, organization and time management skills. Caneffectively and efficiently manage and complete multiple, large-scale and complex priorities andprojects on-time and on-target. = 623; Demonstrates Roche Values and Core Competencies. = 623; Able to deal with ambiguity and constant change. = 623; Able to work independently with minimal supervision. = 623; Able to function effectively in a fast-paced, multi-tasking environment. = 623; Knowledge of regulatory requirements, manufacturing or technical development processes,cGMPs or compliance experience a plus. = 623; International or global business experience and cultural awareness preferred. = 623; Highly Competent in MS office applications including Excel, PowerPoint, Word, Project, etc.Full-time Project located in Greater San Diego area. Must be local.

Reference: 572429571

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