◦Project manage and coordinate the compilation, submission ready quality control, request for sign-off, and post-approval compliance requirements associated with development of Pfizer global clinical study reports (CSRs)
◦Ensure timely delivery of Pfizer global CSRs for regulatory submissions or public disclosure requirements and ensure compliance with regulatory guidelines, specifications, and Pfizer submission standards is achieved
◦Participate in process improvement activities to achieve operational excellence in clinical study report production
Project manage and coordinate compilation, quality control, approval and post-approval processes associated with development of Pfizer global CSRs, including:
•Create CSR mockups in Pfizer Document Management System and populate document templates
•Project manage CSR compilation, approval and publishing activities
•Execute submission ready QC on CSR components and structure
•Communicate with suppliers regarding issues with CSR components and seek resolutions
•Seek approval from signatories on finalized CSRs and update clinical trial registry with CSR milestone status
•Prepare investigator’s declaration packages for distribution to the coordinating investigator
•Prepare study data packages required for distribution to study PIs
•Ensure all CSR activities are executed within agreed timelines and in accordance with working practices.
•Proactively establish and follow clear priorities across portfolio of CSR workload to ensure the timely completion of CSRs contributing to a regulatory submission.
•Where applicable, provide appropriate responses to any audit findings.
•Actively pursue training in technical and personal skills relevant to the CSR Coordinator role.
•Contribute to the achievement of departmental goals by ensuring that targets are incorporated into team and personal goals, and ensure that relevant metrics are collected so that functional line can monitor and address goals, targets and Submission Ready issues.
•In pursuit of maximum efficiency that addresses both speed and quality in document preparation across all therapeutic areas, assure that lessons learned are shared and applied across programs, and carry out established strategies to achieve continuous process improvement towards excellence in document management.
•Where appropriate, act as mentors to newly appointed CSR Coordinators
Technical Skill Requirements
•Attention to detail and exceptional organizational skills
•Proficiency in English language (read, written and spoken)
•Track record of excellence in coordination skills
•Experience in clinical study operations or regulatory operations preferred
•Experience in project management preferred
•Experience in electronic document management preferred
•Experience in multinational company preferred
•Qualifications (i.e., preferred education, experience, attributes)
• Master or bachelor degree in biological, medical, or pharmaceutical sciences preferred