Regulatory Project Manager

Pfizer
Bothell, WA Full Time
POSTED ON 5/18/2024 CLOSED ON 6/15/2024

What are the responsibilities and job description for the Regulatory Project Manager position at Pfizer?

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.

What You Will Achieve

You will oversee and manage oncology regulatory programs for products in various stages of the drug development lifecycle. You will support our programs by developing, maintaining, tracking, and managing high-quality program timelines, dashboards, and team sites to enable accurate team reporting and decision making. You will assess project issues and develop resolutions to meet productivity, quality and client satisfactions goals.

As a Manager, you will provide guidance to operational teams for managing projects. You will assist in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. You will work towards advancing new concepts and methodologies. You will lead/ facilitate agreements between different teams.

How You Will Achieve It

  • Lead projects with multiple deadlines, provide guidance and manage own time to meet objectives.
  • Plan and schedule project timelines and milestones using appropriate tools.
  • Forecast and plan resource requirements (people, financial and technology) for projects across the department.
  • Manage and participate in pre-studies, projects and other activities for increasing operational efficiencies, change in business strategies or in support of operational imperatives.

Qualifications

Must-Have

  • Bachelor's Degree
  • 5 years of experience leading projects in a highly regulated environment
  • Experience successfully managing multiple projects with multiple deadlines
  • Experience in commercial / customer facing roles across the business
  • Knowledge of the of pharmaceutical manufacturing and associated processes
  • Experience in a Pharmaceutical Good Manufacturing Practices/cGMP environment
  • Familiarity with Pharmaceutical Sciences infrastructure
  • Excellent oral and written communication skills
  • Proficiency with Microsoft applications

Nice-to-Have

  • Master's degree
  • Experience managing pharmaceutical/technical/medical devices projects and/or clinical programs
  • Experience leading regulatory submissions for drug applications
  • Experience with Microsoft Project, Planisware, and/or OnePage
  • Knowledge of and certification in operational excellence methodologies (e.g., Six Sigma, Lean)

Physical/Mental Requirements

Bending, reaching, lifting and carrying 10 pounds, working mainly at a desk on a computer, keyboard, mouse, and screens

Relocation assistance available

The annual base salary for this position ranges from $83,500.00 to $139,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. 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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