Senior Regulatory Project Manager

United States - Washington – Bothell

Full time

Posted 6 Days Ago

4915086

Our Purpose

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

Explore our mission

Our Values

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.

Learn our four core values

Cambridge

Benefits

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Read about our benefits

Pfizer, We are one

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.

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 satisfactions goals.

You will lead complex projects across the division, including anticipating and troubleshooting roadblocks and influencing teams to achieve targets for the division.

goals.

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.
Participate in regional operations meetings focused on project performance.
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.
Monitors team performance and proactively alerts team and management about deviations from plan.

Qualifications

Must-Have

Bachelor's Degree
7+ years of experience leading projects in a highly regulated environment
Cross-functional project management experience
Knowledge of drug development including a thorough understanding of the processes associated with feasibility, clinical study start-up and business operations
Outstanding project management and organizational skills
Excellent presentation and communication skills
Experience successfully managing multiple projects with multiple deadlines
Knowledge of the pharmaceutical manufacturing and associated processes
Experience in a Pharmaceutical Good Manufacturing Practices/cGMP environment
Familiarity with Pharmaceutical Sciences infrastructure

Nice-to-Have

Experience with product development processes within a pharmaceutical or medical device company
Familiarity with clinical trial execution, working with contract research organizations, budget management, and related areas
Experience leading regulatory submissions for drug applications
Experience with Microsoft Project, Planisware, and/or OnePage
Project Management Professional (PMP) certification

Relocation support available

Work Location Assignment: Flexible

The annual base salary for this position ranges from $99,900.00 to $166,500.00. 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. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

Continuous Imprv and Proj Mgmt

Breakthroughs that change patients’ lives

Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.

Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:

“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.

“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.

“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.

Our Values

To fully realize Pfizer’s purpose, 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.

The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.

Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.

Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.

Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.

Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.

Benefits at Pfizer

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.

Our Competitive Benefits Programs help our colleagues by:

Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.

For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)

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