Why Patients Need You
This is a secondment designed for a colleague who is interested in working on developing their skills in the specific areas described herein. This experience revolves around the role of a Process and Procedural Document Specialist, a vital part of our Process & Procedural Document Management Team (PPDM) within SOP & Training, Clinical Development & Operations, Pfizer Research and Development.
The PPDM team is instrumental in developing procedural documentation that adheres to regulatory requirements and company policies, thereby ensuring excellence through efficient and effective documentation processes. The Process and Procedural Document Specialist secondee will play a crucial role in assisting the PPDM team in developing and managing global clinical, regulatory, safety, medical, and quality management system procedural documents, including policies, SOPs, and work instructions.
What You Will Achieve and How You Will Achieve It
Manage project for overseeing the status of business projects that may impact the global CMCDs and CMCD pipeline.
With assistance, lead a matrix team comprised of global and/or local subject matter experts, business process owners, and key stakeholders, in the development, revision, process mapping, process enhancements, implementation and maintenance of process quality standards and procedural documentation (policies, SOPs and associated documents) for colleagues across Pfizer clinical, medical, safety, regulatory and enterprise quality management system global processes.
Provide strategic recommendations regarding process design, documentation development, change management and supporting systems by understanding the business, organization and associated responsible roles.
Evaluate global procedural documentation against evolving industry/regulatory requirements and expectations, audit/inspection findings, business needs, higher level corporate policies, changes in industry standards and client feedback and trends, and make recommendations for changes when necessary.
Gain valuable insights into managing global process exceptions, goFindIt administration, and metrics. This experience will not only involve working on complex projects but also offer opportunities to develop leadership skills.
Qualifications
Must-Have
BA/BS with 7 years of experience
Knowledge of clinical trial processes
Ability to manage multi-phase complex projects with multiple contributors/collaborators and interact at all levels in a matrix environment.
Strong organizational, planning, and multi-tasking skills.
Knowledge of Pfizer systems, Microsoft suite
Nice-to-Have
Minimum of 5 years of pharmaceutical experience with solid experience in process design and documentation of pharmaceutical business processes (safety, regulatory, medical and/or clinical).
PHYSICAL/MENTAL REQUIREMENTS
None
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
None
Other Job Details
Last Date to Apply for Job: December 13 2024
Eligible for Relocation Package – NO
Secondment 9 months
Work Location Assignment: Hybrid
If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.
Note: This secondment offers a valuable opportunity for professional growth. It will need to be funded by the secondee’s home market.
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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