What You Will Achieve
Reliable documentation services form an essential component of a well-run Regulatory Affairs department. You will be the one entrusted with managing an efficient documentation system, record retention, and information services in compliance with regulatory requirements. You will ensure that procedures are in place to maintain records and interpret all documentation standards, policies, and operating procedure requirements. As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues. It is your dedication and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
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How You Will Achieve It
- Contribute to the completion of project milestones and organize own work to meet project task deadlines.
- Supports the administration of the Vaccine Research Records Management Program in compliance with Records Management policies and procedures and the Enterprise Records Retention schedule.
- Maintains the operations of the physical records room regarding archiving, indexing and retrieval of critical and non-critical physical records.
- Requires a high level of organizational skills as well as task and timeline management.
- Provides one-on-one end-user or group support and training to the scientific community, assisting with technical and procedural requirements as well as providing clarification of document standards and requirements.
- Provides high quality customer service and record assistance through all levels of the organization.
- Serves as a principal contact for training and compliance of electronic laboratory notebooks.
- Actively manages and maintains the electronic archive database including working with programmer on implementing needed system upgrades.
- Ensures compliance of departmental documents with departmental procedures and where applicable, performs job responsibilities in compliance with GLP and all other regulatory agency requirements.
- Provides guidance to maintain the integrity of the archived records.
- Provides audit support for physical document requests.
- Performs other duties as assigned associated with Records Management initiatives
Qualifications
Must-Have
- Bachelor's Degree with 0-2 years of experience.
- Maintains familiarity with company product ranges and ensuring compliance with regulations
- Robust knowledge of electronic repositories and document management systems
- Good interpersonal and communication skills
- Fluency in written and spoken English
- Demonstrated ability to work under general supervision
- Excellent computer skills in Microsoft Office Suite, Adobe Acrobat etc.
Nice-to-Have
- Demonstrated experience in Pharmaceutical industry
- Knowledge of effective training methods
PHYSICAL/MENTAL REQUIREMENTS
- Light lifting of documents and/or boxes.
Other Job Details:
- Work Location Assignment: On Premise
- On Premise colleagues work in a Pfizer site because it's needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site.
The annual base salary for this position ranges from $60,900.00 to $101,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% 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.
Regulatory Affairs