8 days old

Clinical Study Report Coordinator, Asso. I

Hedgesville, WV 25427
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Summarize the primary purpose & key accountabilities of the job.

+ Project manage and coordinate thecompilation, submission ready quality control,request for sign-off, and post-approval compliance requirementsassociated withdevelopment of Pfizerglobalclinicalstudyreports (CSRs)

+ Ensure timely delivery of Pfizer global CSRs for regulatory submissions or public disclosure requirements andensure compliancewith regulatory guidelines, specifications, and Pfizer submission standards is achieved

+ Participate in process improvement activities to achieveoperationalexcellence in clinical study report production


Indicatethe primaryresponsibilities critical to thejob.

Project manage and coordinate compilation, quality control, approval and post-approval processes associated with development of Pfizer global CSRs, including:

+ CreateCSR mockupsin PfizerGlobalDocumentManagement Systemand populate document templates

+ ProjectmanageCSRcompilation, approvaland publishing activities

+ ExecutesubmissionreadyQC onCSR components and structure

+ Communicatewithcontributorsregarding issues withCSR componentsandseek 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

+ Coordinatethe compilation and signoffofthe otherCSR related componentssuch as Public Disclosure Synopsis (PDS), Plain Language Summary Report Synopsis (PLSRS), etc.


+ Ensure all CSR activities are executed within agreed timelines and in accordancewithglobaland local CMCDs

+ Proactively establish and follow clear priorities across portfolio of CSR workload to ensure the timelycompletion 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 theCSR Coordinatorroleespecially problem-solving skills to daily issues with cross-functional study team, medical writing, regulatory, etc.

+ Contribute to the achievement of departmental goals byincorporateingtargetinto team/personalgoalstoensuretherelevant 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 appointedCSR Coordinators


Indicate qualifications and skillsthat are necessary for performance ofresponsibilities including: education,relevantexperience,licenses,certificationsand other job-related technical and managerial skills.

+ Master orBachelor'sdegree in biological, medical, or pharmaceutical sciences preferred

+ Attention to detail and exceptional organizational skills

+ Proficiency inEnglish 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


Provide the primary groups or key role(s) that this role willhave interaction withas a regular part of theJobresponsibilities. Include any external interactions as appropriate.

+ Reportsto:CSR TeamManager

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

Regulatory Affairs

Posted: 2021-06-11 Expires: 2021-07-12
Sponsored by:
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Clinical Study Report Coordinator, Asso. I

Hedgesville, WV 25427

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