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Job Description

Primary Responsibilities


  • Communicate WWS’s position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed.
  • Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations.
  • Drive the document strategies and messages in a collaborative way with relevant project team subject matter experts.  Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
  • Deliver assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality.
  • If overseeing the work of or leading a team of other authors (internal or external), be accountable for timely delivery of high-quality, fit-for-purpose documents to the project team.
  • Produce documents in conjunction with external vendors.  Review documents produced by vendors and help evaluate vendor performance.
  • Understand relationships and dependencies between documents and analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and ACOs.  
  • Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents.
  • Develop and sustain constructive relationships within other Pfizer lines including country organizations.
  • If assigned by manager, serve as the WWS ‘point of contact’ for all document issues for a given product or set of products.
  • Identify potential areas for process improvements and possible solutions, and communicate these to line management or appropriate functional line.
  
Work Location Assignment: Hybrid

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


Medical#LI-PFE
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