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.

Responsibilities

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.

Qualifications

Must-Have

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

Nice-to-Have

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.