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 integral 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