Pfizer

Electronic Documentation Specialist

Employer
Pfizer
Location
Pearl River, New York
Salary
Competitive
Posted
June 04 2021
Ref
4812112
Position Type
Full Time
Organization Type
Pharma
Why Patients Need You

The ever-changing regulatory environment makes it necessary that Pfizer has a knowledgeable and skilled Regulatory Affairs team. You will be part of a dynamic team that reviews and interprets the increasing regulatory requirements and their associated commercial pressures to facilitate the best patient care. Our patients need dedicated colleagues like you who are experts in their field and can keep their well-being as their topmost priority.

What You Will Achieve

You will be responsible for compliant use of and preparation of documentation in support of high profile programs for Vaccine Research & Development (VRD) by processing electronic workflows with submission ready documentation using a Documentum based system (GDMS). This requires robust technical knowledge of electronic repositories and submission ready requirements. As an associate, your focus on the job will contribute in achieving project tasks and goals. You will understand the criticality associated with high profile programs and how the work impacts the entire organization as well as high level stakeholders. Balance and prioritization skills, as well as task and timeline management are key to your success. You will guarantee that the integrity of documents is consistently preserved and upheld. You will ensure that the completion of all VRD documents meets GxP/cGLP requirements, and that departmental standards within the Vaccine Research organization are upheld. It is your dedication and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

You will work independently with scientists and other stakeholders and be responsible for compliant use of and preparation of documentation in support of high profile programs for Vaccine Research & Development (VRD). The Individual will facilitate and be responsible for electronic workflows with submission ready documentation using a Documentum based system (GDMS). This requires robust technical knowledge of electronic repositories and submission ready requirements. Will also understand the criticality associated with high profile programs and how the work impacts the entire organization as well as high level stakeholders. Incumbent should possess a high level of organization and prioritization skills as well as task and timeline management. This position requires the ability to transfer knowledge and will interact with all levels of the organization including, but not limited to, the senior leadership team as well as global colleagues. Will ensure that the completion of all VRD documents meets GxP/cGLP requirements, and that departmental standards within the Vaccine Research organization are upheld. Must be flexible to provide high level knowledge of other roles within the group quickly, to meet extremely aggressive timelines.

  • Proactively prepares, submits, coordinates and follows up on all document details, workflows and processes. Completes electronic workflows for documentation created, promoting the daily work activities of the Vaccine Research areas, e.g., Procedures and Training Documents and other types of documents, e.g., Test Methods, controlled forms, curriculum vitaes (CV) and job descriptions (JD).
  • Will be one of the primary information sources for scientists and other staff regarding electronic workflows within the documentation system. They are the knowledge source for scientist on formatting, structure and process of documents through the electronic workflow process.
  • Will be held accountable for team and VRD project deliverables and maintaining document metrics.
  • Uses excellent judgement when prioritizing work and understands the criticality associated with high profile programs and ensures all timelines are consistently met.
  • Will collaborate with project management on all high-profile program document deliverables.
  • Develops and maintains constructive working relationships with members of the scientific community, all levels of senior leadership team and global colleagues.
  • Proven ability to speak to large groups of people to provide system and process flow training to the VRD Scientific community.
  • Possesses the ability to comprehend system processes at a high level and is able to independently identify system issues and discrepancies that may occur and communicate them to Records and Information Management (RIM) and Content Management Solutions (CMS). Trouble-shoot and remediate system issues when applicable.
  • Will work closely with the GDMS technical teams to help rectify or improve the system(s) efficiency.
  • Responsible for the periodic review of all documents and procedures, ensuring therequired due dates are consistently met preserving document integrity.
  • Ensures compliance of departmental documents with departmental procedures.
  • Assists during audits as necessary, providing documentation related to Procedures and Training.
  • All work is performed in coordination with manager to assure Vaccine Research documents are prepared, submitted, archived and maintained according to established procedures and regulations.
  • Will have the ability to work remotely as needed


Qualifications
  • BA/BS degree required, plus minimum two years of relevant experience.
  • Excellent computer skills - Microsoft Windows, Microsoft Teams/Meetings, Office Suite, Adobe Acrobat Professional and knowledge of Java required.
  • Demonstrated ability to work under aggressive timelines on a daily basis and possesses strong problem solving abilities.
  • Robust knowledge of electronic repositories and Documentum based systems, GDMS.
  • Increased knowledge of submission ready requirements.
  • Proven ability to effectively communicate and transfer knowledge to end-users utilizing Microsoft Teams Meetings. Meetings may be one-on-one or in groups. Proven knowledge of effective training methods.
  • Ability to plan, prioritize and organize work with no supervision. Self-motivation and ability to work effectively as part of a team required.
  • Strong oral and written communication skills.

Must-Have
  • Bachelor's Degree.
  • Proven ability to speak one-on-one or to large groups of people to provide system and process flow training.
  • Knowledge of effective training methods.
  • Increased knowledge of submission ready requirements.
  • Robust knowledge of electronic repositories and document management systems.
  • Good interpersonal, communication and demonstrated ability to work under aggressive timelines on a daily basis.
  • Strong problem solving abilities.
  • Fluency in written and spoken English.
  • Excellent computer skills - Microsoft Windows, Microsoft Teams Meetings, Office Suite, Adobe Acrobat Professional and knowledge of Java required.


Nice-to-Have
  • Demonstrated experience in Pharmaceutical industry
  • Prior knowledge of local regulatory environment and regulations


PHYSICAL/MENTAL REQUIREMENTS

NA

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

NA

  • Eligible for Employee Referral Bonus


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.

Regulatory Affairs