Pfizer Regulatory Submission Professional in Pearl River, New York
Why Patients Need You
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.
What You Will Achieve
You will help us in preparation, publication, tracking and quality control of our submissions to the regulators in compliance with industry document management standards. You will be responsible for activities handled through enterprise-wide regulatory management systems, including work prioritization, training authors, and developing reference materials.
As an associate, your focus on the job will be to contribute to project tasks and goals and participate in and maintain a collaborative team environment.
It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
Conduct format reviews of documents, including documentation supporting regulatory submissions, to ensure alignment with proper templates and submission standards. Review MS Word documents formatting for structure, compliance, fonts, tables, bookmarks, hyperlinks etc. and to ensure portable document format (PDF) can be viewed, printed, and electronically transmitted. Ensure documents electronic renditions formatting and navigations meet submission-ready standards.
Serve as document coordinator for various Documentum systems and provide one-on-one support to members of scientific community in support of regulated documentation formatting requirements, including but not limited to oversight of processing and timely completion of electronic workflows.
Collaborate with project team leaders, regulatory strategists, submission scientist colleagues, and authoring community to share knowledge, align expectations and establish action plans to support documentation activities.
Ensure all company standards, policies and requirements are met and consistent document standards are applied to all documents.
Share with authoring community updates and/or interim revisions of the company submission standards and requirements.
Perform other duties as assigned associated with submission and records management initiatives. Contribute to content related to document management and submission readiness processes.
Review performance standards and serve a critical role in ensuring technology updates, process improvements, and other operational initiatives within the regulatory documentation submission processes/systems rollout to seamlessly to the authoring community.
How You Will Achieve It
Organize own work to meet project task deadlines and project milestones and applicable regulatory obligations are met.
Execute, through use of standards and tools and designated operational tasks that all work conforms to regulatory submission standards.
Promote quality as a best practice based on knowledge of regulatory requirements, departmental guidelines, and Quality Control (QC) experience.
Contribute to effective project management utilizing resources and normal business practice.
Communicate with internal team members about execution and strategy as needed.
Actively pursue training in technical and personal skills relevant to the job requirements.
Act as a subject matter expert for the contributing community and cross functional teams.
Bachelor's Degree and/or years of demonstrated experience.
Knowledge of managing the compliant use of electronic document management systems associated with, but not limited to, regulatory activities, and/or documentation of the programs using various Documentum based systems.
In-depth understanding of systems and electronic technologies used to support documentation activities, as well as demonstrated experiences in process development and new technology implementation.
Demonstrated ability to work under minimal supervision and aggressive timelines.
Ability to effectively transfer knowledge to end-users in both a one-on-one situation and in group settings, knowledge of effective training methods.
Demonstrated coordination of activities in a highly regulated environment.
Demonstrated experience working in a challenging customer service environment.
Knowledge of the Pharmaceutical industry.
Strong IT skills, advanced use of MS Word and Adobe Acrobat.
Good knowledge of spoken and written English
- Experience in project management
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Work schedule is a 40-hour week during core business hours, Monday through Friday.
Project priorities occasionally necessitate work beyond regular work hours, including evenings and weekends.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Some overtime work might be required.
Work Location Assignment:On Premise
Other Job Details:
Eligible for relocation package
Eligible for employee referral bonus
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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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