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.

What You Will Achieve

You will oversee and manage operational aspects of ongoing improvement projects, acting as a liaison between Project Team and Line Management. You will support our programs by managing the review of the status of the project, budget, schedules and preparing status reports. You will assess project issues and develop resolutions to meet productivity, quality and client satisfactions goals.

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of this discipline, you will work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

* Lead projects, 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

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Must-Have

* Degree in life sciences and/or in regulatory compliance/oversight related field.

* Demonstrated understanding of regulatory requirements and application of quality systems (GLP, GCP, GCLP, CLIA, CAP).

* In depth knowledge and experience in diagnostics, particularly companion diagnostics.

* 3+ years of relevant regulatory compliance/oversight experience in a setting relevant to drug development.

* Demonstrated excellent writing and communication skills.

Nice-to-Have

* In depth and hands-on experience in one or more technology platforms relevant to CDx assay development, such as immunohistochemistry, PCR, next generation sequencing.

* Extensive hands-on experience with compliance/oversight of diagnostics assays.

* Experience in biomarker development or diagnostics industry.

Other Job Details:

* Eligible for Employee Referral Bonus: YES
* Eligible for Relocation: YES

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 providers 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.

Continuous Imprv and Proj Mgmt

LI-PFE