**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **Job Description** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. **Location:** **2244 Dabney Road,** **Richmond, VA** **Schedule: Office based, Monday-Friday (8am-5pm)** **Division Specific Information** **:** Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. **Discover Impactful Work:** Provides administrative and technical support to Project Team including planning, organizing and coordinating responsibilities of project administration. Maintains procedures, guidelines and documentation. Ensures appropriate maintenance of project records and that all regulatory documents are correct, processed and approved. Completes' data entry and maintenance of data base repositories. Assists in preparation or creation of reports and completes data collection for analysis. Completes quality review and demonstrates audit readiness. **A day in the life:** + Completes review, coordination and compilation of files and other materials. Distributes project documents and supplies. + Processes and tracks local regulatory, study specific or department documents. + Performs file review. Organizes and maintains correspondence files and other departmental records. Analyzes and reconciles project documents, metrics and findings reports within specified timelines. + Provides clarification and resolution of findings related to documentation. + May assist with translation materials and translation QC upon request. + Composes, copies and distributes communications, reports, documents and + forms. Performs mass mailings and communications. + Maintains vendor trackers. + Provides accesses to company, client and vendor systems. + Processes local payments (translations, EC/IEC, other local vendors, etc.) + Assists on project management ad-hoc activities, producing reports or on study plan edition. + Coordinates team conference calls and completes and distributes meeting minutes from internal/client/vendor meetings as applicable. + Maintains a working knowledge of applicable GCPs, organization and client SOPs and/or protocol-related specifics through professional career development to ensure continued compliance. + Maintains a basic knowledge of project protocol and the ability to implement project plans with specific guidelines and accountable for meeting applicable project timelines in accordance with the contract. + Serves as a resource to the project team. + Assists in ensuring audit ready files. Contributes to company, client and federal regulatory requirements/audit responses as needed. + Acts as a mentor for research and project teams by demonstrating the role of an experienced senior project assistant in the preparation and execution of all administrative functions. + Assists in training junior staff and supports departmental leadership in determining training needs. **Education:** + High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification **Experience:** + Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 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:** + Self-motivated, positive attitude with effective oral and written communication and interpersonal skills + Ability to work in a team or independently as required + Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively + Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency + Strong customer focus + Strong flexibility to reprioritize workload to meet changing project timelines + Demonstrated ability to attain and maintain a good working knowledge of applicable regulations and procedural documents for all non-clinical/clinical aspects of project implementation, execution and closeout + Solid English language and grammar skills + Good presentation skills + Firm computer skills, proficient in MS Office, ability to obtain knowledge and master all database systems and modern technology + Solid critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving + Skills to work under constant pressure to meet project/client deliverables and timelines + Ability to successfully complete required training program(s) as applicable + Intermediate excel knowledge need **Working Environment:** Thermo Fisher Scientific values the health and wellbeing 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.) **Benefits** We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! 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.