Use Your Power for Purpose
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines. 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
What You Will Achieve
In this role, you will:
- As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team.
- Your focus and ability to meet team targets will help in completing critical milestones on time.
- Your innovative use of communication tools and techniques will facilitate in addressing difficult issues and establishing consensus between teams
- It is your focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
- 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
Here Is What You Need (Minimum 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
Bonus Points If You Have (Preferred Requirements)
- 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
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.
Regulatory Affairs
