9 days old

CSR Coordinator

Pfizer
Hedgesville, WV 25427
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**JOB SUMMARY**



Summarize the primary purpose & key accountabilities of the job.



+ 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



**JOB RESPONSIBILITIES**



Indicate the primary responsibilities critical to the job.



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 Global 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 contributors 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

+ Coordinate the compilation and signoff of the other CSR related components such as Public Disclosure Synopsis (PDS), Plain Language Summary Report Synopsis (PLSRS), etc.



Generally:



+ Ensure all CSR activities are executed within agreed timelines and in accordance with global and local CMCDs

+ 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 especially problem-solving skills to daily issues with cross-functional study team, medical writing, regulatory, etc.

+ Contribute to the achievement of departmental goals by incorporating target into team/ personal goals to ensure the 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



**QUALIFICATIONS / SKILLS**



Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.



+ Master or Bachelor's degree in biological, medical, or pharmaceutical sciences preferred

+ 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



**ORGANIZATIONAL RELATIONSHIPS**



Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.



+ Reports to: CSR Team Manager



**RESOURCES MANAGED**



N/A



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Regulatory Affairs



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Posted: 2021-06-11 Expires: 2021-07-12
Sponsored by:
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CSR Coordinator

Pfizer
Hedgesville, WV 25427

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