Pfizer, S.A. de C.V
Senior Regulatory Project Manager
Pfizer, S.A. de C.V, Bothell, Washington, United States, 98021
We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.At Pfizer, our mission is to inspire a best-in-class culture of continuous improvement and project management that empowers colleagues and enables simple, effective processes. Whether you are managing projects or liaising with others, your contribution in this team will help in making our work easier and faster so that we can deliver breakthroughs that change patients' lives.Position Summary
You will oversee and manage operational aspects of ongoing regulatory projects, acting as a liaison between the project teams and the line management. You will support our programs by managing the status review of the project, budget, schedules and preparing reports. You will develop mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers, and clients. You will assess project issues and develop resolutions to meet productivity, quality and client satisfaction goals.You will lead complex projects across the division, including anticipating and troubleshooting roadblocks and influencing teams to achieve targets for the division.Key Responsibilities
Develop ideas, manage plans to achieve objectives and lead or co-lead projects across the division.Facilitate the development, implementation and management of business strategies.Manage the development of the project plan with cross functional teams to deliver the program on time, within schedule, and within budget.Develop and execute communication plan to ensure effective and timely communication between the core Team and functional management, senior management, and external partners.Prepare periodic management and progress reports.Promote a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity.Provide project information necessary to support portfolio-level decision making and prioritization.Coordinate and ensure long-range needs for expansion of production equipment, identify novel upstream and downstream processes and assimilate them into the relevant work streams.Capitalize on the foundation of knowledge in the areas of Pfizer historic study performance data, competitor trial performance, real world data, and industry benchmarks using a variety of analytic and modeling tools.Monitor team performance and proactively alert team and management about deviations from plan.Qualifications
Must-Have
Bachelor's Degree7+ years of experience leading projects in a highly regulated environmentKnowledge of drug development including a thorough understanding of the processes associated with feasibility, clinical study start-up and business operationsOutstanding project management and organizational skillsExcellent presentation and communication skillsExperience successfully managing multiple projects with multiple deadlinesKnowledge of the pharmaceutical manufacturing and associated processesExperience in a Pharmaceutical Good Manufacturing Practices/cGMP environmentFamiliarity with Pharmaceutical Sciences infrastructureNice-to-Have
Experience with product development processes within a pharmaceutical or medical device companyFamiliarity with clinical trial execution, working with contract research organizations, budget management, and related areasExperience leading regulatory submissions for drug applicationsExperience with Microsoft Project, Planisware, and/or OnePageProject Management Professional (PMP) certificationPHYSICAL/MENTAL REQUIREMENTS
Lifting, sitting, standing, walking, bending, ability to perform critical thinking.The annual base salary for this position ranges from $109,400.00 to $182,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.Why Patients Need You
At Pfizer, our mission is to inspire a best-in-class culture of continuous improvement and project management that empowers colleagues and enables simple, effective processes. Whether you are managing projects or liaising with others, your contribution in this team will help in making our work easier and faster so that we can deliver breakthroughs that change patients' lives.
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You will oversee and manage operational aspects of ongoing regulatory projects, acting as a liaison between the project teams and the line management. You will support our programs by managing the status review of the project, budget, schedules and preparing reports. You will develop mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers, and clients. You will assess project issues and develop resolutions to meet productivity, quality and client satisfaction goals.You will lead complex projects across the division, including anticipating and troubleshooting roadblocks and influencing teams to achieve targets for the division.Key Responsibilities
Develop ideas, manage plans to achieve objectives and lead or co-lead projects across the division.Facilitate the development, implementation and management of business strategies.Manage the development of the project plan with cross functional teams to deliver the program on time, within schedule, and within budget.Develop and execute communication plan to ensure effective and timely communication between the core Team and functional management, senior management, and external partners.Prepare periodic management and progress reports.Promote a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity.Provide project information necessary to support portfolio-level decision making and prioritization.Coordinate and ensure long-range needs for expansion of production equipment, identify novel upstream and downstream processes and assimilate them into the relevant work streams.Capitalize on the foundation of knowledge in the areas of Pfizer historic study performance data, competitor trial performance, real world data, and industry benchmarks using a variety of analytic and modeling tools.Monitor team performance and proactively alert team and management about deviations from plan.Qualifications
Must-Have
Bachelor's Degree7+ years of experience leading projects in a highly regulated environmentKnowledge of drug development including a thorough understanding of the processes associated with feasibility, clinical study start-up and business operationsOutstanding project management and organizational skillsExcellent presentation and communication skillsExperience successfully managing multiple projects with multiple deadlinesKnowledge of the pharmaceutical manufacturing and associated processesExperience in a Pharmaceutical Good Manufacturing Practices/cGMP environmentFamiliarity with Pharmaceutical Sciences infrastructureNice-to-Have
Experience with product development processes within a pharmaceutical or medical device companyFamiliarity with clinical trial execution, working with contract research organizations, budget management, and related areasExperience leading regulatory submissions for drug applicationsExperience with Microsoft Project, Planisware, and/or OnePageProject Management Professional (PMP) certificationPHYSICAL/MENTAL REQUIREMENTS
Lifting, sitting, standing, walking, bending, ability to perform critical thinking.The annual base salary for this position ranges from $109,400.00 to $182,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.Why Patients Need You
At Pfizer, our mission is to inspire a best-in-class culture of continuous improvement and project management that empowers colleagues and enables simple, effective processes. Whether you are managing projects or liaising with others, your contribution in this team will help in making our work easier and faster so that we can deliver breakthroughs that change patients' lives.
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