Management of process and compliance for all Vaccines R&D Laboratory Notebooks physical) and electronic (Biobook) in accordance with R&T 003. This includes being the lead contact for any audits/inspections around the Lab Notebook process/procedure and representing VRD on the WRDM-wide Laboratory Notebook Compliance Committee. Requires SME knowledge of both Biobook system and Accelrys software.
Supervision of the VRD physical Records Room. SME knowledge of records management standards and best practices including but not limited to taxonomy and disposition of company records as well as setting policies and procedures for the handling of said records. This position also requires the ability to transfer knowledge to Records Room staff and supervision of their work, and to provide customer support through all levels of the organization including senior leadership.
Provide guidance and support to VRD authors and VRD Non-Clinical Publication Board in the preparation and filing of non-clinical publication process.
SME knowledge for managing the compliant use of electronic workflows associated with submission ready documentation of the VRD programs using Documentum based systems (GDMS/Gnosis).
This position backs up the role of the Manager, Records and Documentation Management.
Requires a high level of organization skills, task and timeline management.
Requires ability to effectively communicate with all levels of VRD organization and WRDM leadership.
Ensures compliance with departmental procedures.
Process owner and SME contact for quality control of all physical and electronic (Biobook) laboratory notebooks including but not limited to performing regular audits of all laboratory notebooks, providing regular reports to VRD management to ensure compliance to WRDM standards, supports scientists and Pfizer systems owners to resolve issues/discrepancies.
Manages work of Records Room Staff with issuance, tracking and archiving of the all physical records.
Primary responsibility for physical records and laboratory notebook requests during audits and provides overall assistance with all requested documentation.
Authorship of policies related to VRD Records Room and archiving of VRD physical records, working in conjunction with VRD management.
Responsible adherence to Pfizer Records Retention Schedule and off-site storage policies.
Responsible for working with Pfizer systems personnel on the maintenance and enhancement of VRD proprietary Records Management system.
Knowledge of WRDM non-clinical publication process; provide guidance to VRD authors and VRD Publication Board on filing process. Provide ongoing support to VRD Non-Clinical Publication Committee.
Acts as information source for Scientists and other staff regarding electronic workflows within the documentation systems. Offers guidance to document authors on document workflow and provides clarification of document standards and requirements. They are the knowledge source for Scientist on formatting, structure and process of documents through the electronic workflow (creation, Revision, Approval and Obsolescence).
Requires SME technical knowledge of Pfizer electronic documentation systems/repositories and submission ready requirements.
Provides one-on-one end-user or group support and training to the VRD scientific community, assisting with technical and procedural requirements as well as providing clarification of document standards and requirements.
Provides one-on-one support to members of Vaccine Research & Development (VRD) scientific community in support of regulated documentation, included but not limited to oversight of processing and timely completion of electronic workflows.
Comprehends GDMS/Gnosis system processes and communicates system discrepancies that may occur. Provides SME support to VRD scientific community and works with GDMS/Gnosis technical teams to help rectify or improve the system(s) efficiency.
All work is performed in coordination with manager to assure Vaccine Research documents are archived and maintained according to established procedures and cGMP Regulations.
Satisfactorily completes all required training in conformance with departmental requirements.
Performs other duties as assigned associated with Records Management initiatives.
Responsible role of Manager, Records and Documentation Management.
Supervision of two direct reports.
Bachelor s degree and 3 years of relevant experience required.
Excellent computer skills Microsoft Windows and Office Suite and Adobe Acrobat Professional.
SME knowledge of records management systems, policies, and procedures.
SME knowledge of electronic workflows and Pfizer electronic documentation repositories.
Ability to effectively transfer knowledge to end-users in both a one-on-one situation and in group settings; knowledge of effective training methods.
Ability to plan, prioritize and organize work, self-motivation and ability to work effectively as part of a team.
Ability to effectively direct the work of others.
Demonstrated ability to work under minimal supervision and aggressive timelines.
Strong oral and written communication skills.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel to other research sites might be required.
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.
Other job details:
Last date to Apply for the job: July 16, 2019
Eligible for Employee Referral Bonus
1 (First Shift) (United States of America)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.