Job Description

　　Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner.

　　Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

　　Responsibilities:

　　Coordinate and execute non-GxP study documentation, management of research and development externalized activities, and oversight of study processes for US Vx R&D.Maintain good documentation practices and quality compliance as related to existing quality management systems.Interface with relevant stakeholders in quality, pharma, scientific leads, etc. to strive for driving pipeline progress and study execution, as defined by study deadlines.Perform regular review of processes, documentation, and records for studies within Viral Vx R&D. Responsible for building, maintaining, and reporting on metrics related to study monitoring, management, and completion for Viral Vx R&D.Organize and ship materials to and from study sites and third parties.Facilitate externalization of non-GxP activities with third parties

　　Basic Qualifications:

　　BS Degree in Science from an accredited universityAt least 1-2 years of work experience in a laboratory setting and/or business environmentProject management and a scientific backgroundUnderstanding of scientific lab activities (operations, logistics, quality, in vivo and in vitro assays) is a key requirement for this role

　　Preferred Qualifications:

　　Experience & understanding of scientific lab activities including experience with equipment lifecycle management & commissioning of equipment, as well as risk & issue management at a corporate levelExperience with audits, investigations and other regulatory quality and risk management assurance activitiesAnalytical problem solving (trouble shooting) skills - thinks strategically, applies a creative approach to problem solving, challenges the status quo; ability to analyze current situation, evaluate pros & cons of potential options, and recommend solutions.Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor, and riskEffective time management, ability to clearly identify and manage multiple completing prioritiesStrong interpersonal skills, builds relationships and works collaborativelyEffective influencing, negotiation, and communications skills - ability to convince

　　As a condition of employment with PPD, part of Thermo Fisher Scientific, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.