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.
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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
- 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
- Experience with Polish Site Payments.
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
Work Location Assignment: Hybrid
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Pursuant to Article 24(6) of the Act of June 24, 2024 on the protection of whistleblowers, Pfizer Polska Sp. z o.o. and Pfizer Trading Polska Sp. z o.o. declare that they have adopted a joint internal reporting procedure, which, in accordance with the provisions of the aforementioned Act, is also available to persons applying for employment on the basis of an employment relationship or other legal relationship constituting the basis for providing work or services or performing functions. The content of the procedure is made available upon request sent to the contact person or to the email address sygnalisci-px@pfizer.com.
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