Why Patients Need You
Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
What You Will Achieve
You will facilitate in conducting clinical trials and monitoring their progress. You will coordinate all activities that support the clinical trials and assist the managers in conducting them. As an associate, your focus on the job will contribute in achieving project tasks and goals. It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Contribute to completion of project milestones and organize own work to meet project task deadlines.
Maintain Pfizer Trial Master File (PTMF) in accordance with International Council for Harmonization - Good Clinical Practice (ICH-GCP) and Standard Operating Procedures (SOPs).
Review shared space to ensure others are updating tracking and files as requested by the team.
Update the trial and site information as necessary in Corporate Clinical Trial Registry in a timely manner.
Support and coordinate the Clinical Trial Application to ethics committee and regulatory authority, if applicable, to obtain approval within required timeline.
Provide protocol and Informed Consent Document (ICD) Administrative Support to global Project Managers and Study Managers.
Support and coordinate any activities as requested by PMs/SMs and as assigned within required timelines.
Maintain / develop local tracking spreadsheets for study-related documents, data, activities and prepare site supportive material.
Attend appropriate training programs and project teleconferences as applicable.
Assist team with the preparation of any documents or tracking and updating information.
Identify and implement process improvements for inspection readiness, Pfizer Trial Master File (PTMF) compliance, Investigator Meeting organization.
Ensure the reconciliation of Trial Master File and the Site Master File on a periodic basis.
Qualifications
Must-Have
Bachelor's Degree with 2+ years of experience.
Relevant work experience in a health-related discipline, pharmaceutical or medical research
Demonstrated ability to introduce new ideas
Knowledge on all relevant Standard Operating Procedures
Ability to prioritize multiple tasks and develop strategies for completion of all required activities
Ability to build collaborative working relationships with colleagues and associates both within and external to the organization
Nice-to-Have
Experience in management of clinical trial and/or regulatory documents
Knowledge of International Conference on Harmonization Good Clinical Practices and local regulations
Knowledge of application used in the clinical trials
Other Job Details:
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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