Work Schedule
Standard (Mon-Fri)

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

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.

• Prepares and/or assists in the preparation of scientific documents such as next time point creates or other basic shell creation. Ensures that hardcopy and electronic reports are consistent and comply with required formats. Reviews data tables and listings and ensures that errors are corrected. Edits and performs a quality control review of scientific documents prior to creation of the final pdf deliverable. Ensures compliance with PPD, Client, eCTD policy and procedure on publications.
• Reviews technical documents for accuracy, formatting, consistency and compliance to protocols or SOPs.
• May represent the laboratory on project teams and update team members on the status of study reports. Acts as a liaison on interdepartmental projects when reports are required.
• Keeps updated on the guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents. May help write Training Materials Documents and Standard Operating Procedures related to Scientific Writing functions.
• Works with more senior staff on approach for new assignments.
• Performs other duties as assigned.

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years) or equivalent combination of education, training, & experience.

• Working knowledge of scientific terminology, medical, pharmaceutical and research concepts
• Knowledge of word processing, spreadsheets, table and graph generation
• Effective written and oral communication skills
• Detail oriented
• Computer skills including Microsoft Office
• Time management skills
• Good editorial and proofreading skills
• Problem solving and troubleshooting skills
• Ability to work well in a collaborative team environment

• 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 and/or standing for typical working hours.
• Able 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.