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Electronic Documentation Specialist

Employer
Pfizer
Location
Pearl River, New York
Salary
Competitive
Closing date
May 8, 2021

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Sector
Pharmaceutical, Regulatory Affairs
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
ROLE SUMMARY

The incumbent, under the supervision of the Manager Records and Documentation Management, will be responsible for managing the compliant use of electronic workflows associated with submission ready documentation of Vaccine Research Programs using a Documentum based system (Pfizer GDMS). This requires a high level of organization skills, task and timeline management, as well as technical knowledge of electronic documentation systems/repositories and submission ready requirements.

Experience with end user SharePoint Site Administration support and Microsoft Teams including but not limited to: permission management, management of sites, file uploads, etc.

This position also requires the ability to transfer knowledge and provide customer support through all levels of the organization, including the senior leadership team.

ROLE RESPONSIBILITIES
  • 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.
  • Collaborate with Clinical functional lines and disciplines to safeguard documentation compliance. Activities, include but are not limited to Trial Master Files support, scientific resources information support etc
  • Ensures compliance of departmental documents with departmental procedures and where applicable, performs job responsibilities in compliance with GLP and all other regulatory agency requirements.
  • Scans and uploads documents into official repositories, maintaining version control and manages the issuing of document numbers and tracking status of controlled documents.
  • Satisfactorily completes all required training in conformance with departmental requirements.
  • Performs other duties as assigned associated with Records Management initiatives
  • 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.
  • Knowledge of 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 electronic documentation management systems (Documentum), 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.
  • Adaptable to ever changing priorities.
  • Able to easily adapt to changes in software.


QUALIFICATIONS
  • Proficient computer skills - Microsoft Windows, Office Suite, Teams and Adobe Acrobat Professional
  • Basic knowledge of Electronic Document Repositories, preferably GDMS and Gnosis including understanding of electronic workflows and documentation systems
  • Ability to effectively transfer knowledge to end-users in both a one-on-one situation and in group settings; Knowledge of effective training methods
  • Strong oral and written communication skills
  • Ability to plan and organize work, self-motivation and ability to work effectively as part of a team
  • Demonstrated ability to work under general supervision.


PHYSICAL/MENTAL REQUIREMENTS

N/A

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

N/A

  • #LI-PFE


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.

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