Senior Regulatory Project Manager at Pfizer in Bothell, Washington

Job Description:

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.

 

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