Regulatory Affairs Specialist - Customer Dedicated (FSP) contract opportunity

Company: PPD Inc.
Location: Orlando
Posted on: June 25, 2022

Job Description:

PLEASE SUBMIT ENGLISH LANGUAGE RESUMES ONLY* Various Seniority Levels* Home-Based/Remote Based Contract Opportunity* Full Time (FTE 1.0)* 6 month durationDo you prefer flexible work options that allow you to work as a contractor, while also being immersed in the PPD Culture?Apply today to learn more about current and upcoming contractor opportunities through our Functional Service Partnership team.Functional Service Partnership Homepage: Position SummaryProvides 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* 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 Required* Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).* In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills and Abilities* Good English language (written and oral) communication skills as well as local language where applicable Good attention to detail and quality as well as editorial/proofreading skills* Good interpersonal skills to work effectively in a team environment* Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies* Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects* Good negotiation skills* Capable of working independently with direction and exercising independent judgment* Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables* Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management* Basic understanding of medical terminology, statistical concepts, and guidelines* Good analytical, investigative and problem-solving skills* Capable of interpreting dataPPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities.PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role* Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.* Able to work upright and stationary for typical working hours.* Ability to use and learn standard office equipment and technology with proficiency.* Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.* May require travel. (Recruiter will provide more details.)Employees hired in this role may be assigned to a US government contract and if so would be subject to COVID-19 vaccination and reporting requirements.

Keywords: PPD Inc., Orlando , Regulatory Affairs Specialist - Customer Dedicated (FSP) contract opportunity, Other , Orlando, Florida