**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** - Prepares and reviews regulatory submissions. - Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in executing strategies. - Leads the development and implementation of project-specific processes for sponsors. - Collaborates with other departments, regulatory consultants, and regulatory authorities. - Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications. - Participates in project launch meetings, review meetings and project team meetings. - Supports business development activities, including project budgeting/forecasting. - Requires • Not mandatory but preferred experience clinical trials submissions and development • Good organizational and planning skills to effectively manage shifting priorities • Capable of working effectively on a team and/or independently with minimal supervision • Good electronic document production skills • Good proficiency in several computer applications including Microsoft Office software • Good attention to detail and quality of documentation • Good interpersonal skills with the ability to interact with customers • Solid verbal and written communication skills • Capable of multitasking and managing multiple projects Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.