Pfizer
ReportCoordinatorAssociate
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Report Coordinator Associate at Pfizer. Skills: Project management, Regulatory reporting. Lead report preparation. Review data”
What You'll Achieve.
meet regulatory compliance; meet compliance
Industry & Context.
issue resolution skills
What They're Looking For.
Must Have
Excellent English verbal communication, Excellent English written communication, Excellent English presentation skills, project management skills required, issue resolution skills required, Demonstrated ability to perform in a cross-functional environment
Nice to Have
Experience in the pharmaceutical industry, Experience in clinical research, Experience in healthcare related field, Knowledge of regulatory/safety regulations, Knowledge of guidelines desired
What You'll Do.
Lead report preparation
Compile information for reports
Coordinate review and approval
Address review comments
Ensure reports are completed prior to regulatory due
Provide guidance to contributor
Participate in projects
Participate in subject matter tasks
Participate in developing UAT
Perform User Acceptance Testing
How You'll Work.
Team & Collaboration
Partner with various colleagues; Cross-functional environment
Communication Scope
English verbal communication; English written communication; English presentation skills
Process & Methodology
project management
Full Job Description
**Position Purpose** * Individual filling the position are responsible for the project management of safety aggregate reports submitted to regulators that include the FDA and EMA. * The incumbent will partner with various colleagues from Safety, Clinical, Regulatory and other functional lines to produce the aggregate reports and ensure that these reports are completed in a timely manner meeting regulatory compliance. **Primary Responsibilities** * Lead report preparation from prep to submission with key stakeholders/contributors within Clinical, Regulatory, Safety, DevOps, Submissions, etc. * Review data to ensure consistency between various contributors. * Compile the information for reports using various electronic tools and document management system. * Coordinate the review and approval of the report and address review comments. * Ensure reports are completed prior to regulatory due date to meet compliance. * Provide guidance to contributor regarding report requirements. * Participate in projects or subject matter tasks that support the group and deliverables. * Participate in developing and performing User Acceptance Testing (UAT) as required. * Complete training in accordance with Pfizer’s and WSR Safety information Management curriculum. **Technical Skill Requirements** Experience with: * Microsoft Products, (e.g., Word, PowerPoint, Excel, Outlook, Teams) * SharePoint technology * PDF software (e.g., Adobe) Business Objects/Business Intelligence experience is a plus. **Qualifications (i.e., preferred education, experience, attributes)** * Bachelor’s Degree in life sciences, healthcare, or pharmaceutical discipline required. * Experience in the pharmaceutical industry, clinical research, or healthcare related field is preferred. * Excellent English verbal, written communication and presentation skills required. * Must be detailed oriented. * Strong project management and issue resolution skills required. * Demonstrated ability to perform in a cross-functional
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