.We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.If you're a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment — and help get life-changing therapies to patients faster.At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.**Summarized Purpose**:Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services.**Essential Functions and Other Job Information**:Supports the preparation of documentation and submissions under guidance.Coordinates and manages client deliverables supporting regulatory compliance.Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting.Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.Assists in business development and pricing of projects for the department.Evaluates client needs in relationship to overall project timelines, quality and delivery.Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed.**Education and Experience**:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).**Knowledge, Skills and Abilities**:Document writing experience, Protocol amendment, ICF, IB
