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Investigator Initiation Package Senior Associate

Philippines, Makati City · Job Posted February 20, 2026
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Job Description

An Investigator Initiation Package (IIP) Senior Associate will ensure Pfizer maintains compliance by delivering the portfolio of one or multiple applicable regulatory obligations. Investigator Initiation Package Team comprises coordination of regulatory compliance starting at drug development stage and reaching through the lifespan of the Product. Members of this team hold responsibility for verifying presence and consistency of required investigator related documents in the electronic Trial Master File facilitating the release of Pfizer sponsored investigational medicinal product

Job Responsibility

  • Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team
  • Support the interpretation of regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local/regional level
  • Continuous Improvement of selected processes relating to IIP submissions and selected drug and non-drug specific projects and related activities e.g. IIP lifecycle records and scheduled IIP regulatory compliance reporting
  • Delivery of Clinical Study Portfolio
  • Support on global/local teams to complete assignments and tasks within a specific task force/project
  • Provide support of cross-functional teams as appropriate
  • Understand the use of country requirements as they apply to clinical trials
  • Perform internal QC checks to ensure compliance with all SOP and regulatory requirements

Requirements

  • Bachelor's Degree
  • 3+ years of experience
  • Relevant experience in electronic submissions build within the Pharmaceutical Industry
  • Strong knowledge of the drug development process, regulatory affairs, and submission management
  • Understanding of systems and electronic technologies used to support submission and planning activities
  • Attention to detail and exceptional organizational skills
  • Proven experience delivering through others in a team environment
  • Proficient in English, verbal and written

Nice to have

  • Master's degree
  • Relevant pharmaceutical experience
  • Familiarity with pharmaceutical organizational structures, systems, and culture
  • Experience in project management
  • Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

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