Project Support Associate - Document writer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join our team at Thermo Fisher Scientific and contribute to advancing clinical research. As a Client Services Project Manager I, you'll support clinical trials by managing project documentation, coordinating supply chain activities, and ensuring consistent delivery of services. Work closely with internal teams and clients to support study success while maintaining the highest quality standards. You'll handle project planning, documentation management, and cross-functional coordination to meet timelines and client expectations.

Your Role in that Mission:

As a member of Global Client Services, you are part of One Global Team: Empowered to Act, Make Connections and Get Results for our customers and their patients.

The Project Support Associate is a key member of our Project Management team and provides crucial support which enables unparalleled service to our clients. This role partners with internal and external customers to monitor the daily progress of client project results and plays a key role in documentation and ensuring an excellent customer experience. The PSA role supports the PM client portfolio to ensure successful completion and supply maintenance over the life cycle of each project.

Key Responsibilities:

• Partners with the internal project management team to help support the success of a study in any way possible.
• Assists in setting up and maintaining study filing systems and maintains accurate records for all work undertaken, working with appropriate quality management systems.
• Collaborates with the Project Manager for ensuring that all Fisher Clinical activities come together in a timely manner to meet the customer and study requirements.
• Gets results through the use of appropriate project planning tools to communicate achievements and critical path activities and responsibilities.
• Creates and/ or supports creation of operational documentation using internal systems including but not limited to GMP operational documentation. Build bill of materials and coordinates creation and review of billing packages.
• Collects all information on a study design including; accurate label texts, coordination of primary, secondary packaging material and tools, coordination of label translation, producing all batch documentation for operations and check of documentation and GMP instructions.
• Applies GXP in all areas of responsibility

As Demonstrated By:

Project Management

• General understanding of project plans and timeline management with a demonstrated track record for task delivery to enable achievement of goals.
• Knowledge of general inventory, good documentation practices, and report generation.
• Identifies and raises project challenges and collaborates with team members or management to resolve issues.
• Communicates information in a timely manner, understands boundaries, respects differences and addresses challenging situations appropriately.

REQUIREMENTS:
• Bachelor's degree required, no prior experience required, preferably in clinical trials or pharmaceutical industry
• Preferred Fields of Study: healthcare, supply chain management, life sciences, or related field
• Strong understanding of GMP/GxP principles and quality management systems
• Demonstrated project management skills with ability to handle multiple projects simultaneously
• Advanced proficiency in Microsoft Office suite, especially Excel and Project
• Strong analytical and problem-solving capabilities
• Effective written and verbal communication skills
• Detail-oriented with excellent organizational and documentation abilities
• Demonstrated ability to work independently and as part of cross-functional teams
• Fluent English required, additional languages beneficial
• Experience coordinating with teams and managing stakeholder relationships
• Ability to analyze data and generate clear, accurate reports
• Focus on quality service and continuous improvement
• Adaptable to changing priorities while maintaining attention to detail