Project Assistant Clinical Supplies at Thermo Fisher Scientific

• As a Project Assistant, Provides administrative and technical support to Project Team including planning, organizing and coordinating responsibilities of project administration. Maintains procedures, guidelines and documentation. Assists with maintaining project records and ensuring that all regulatory documents are correct, processed and approved. Completes data entry and supports maintenance of data base repositories. Assists in preparing reports and data collection for analysis. Supports quality review

The basic purpose of the Project Assistant is to provide technical support to the project team.

Responsibilities include, but are not limited to;

• Assists with 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.
• Assists with 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.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year). 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, Abilities

Ability to work in a team or independently as required

• Good organizational skills and strong attention to detail, with ability to handle multiple tasks efficiently and effectively
• Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Flexibility to prioritize workload to meet changing project timelines
• 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
• Good English language and grammar skills
• Good computer skills, proficient in MS Office, ability to obtain knowledge and master all database systems and modern technology
• 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.