Work Schedule
First Shift (Days)

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

• Prepares and/or assists in the preparation of procedural documents (SOPs) and associated documentation such as, but not limited to: work instructions, tables, etc. and ensures SOPs and related documentation is consistent and comply with required formats.
• Works with subject matter experts and senior staff and leadership to execute SOP revision and / or creation, and conducts comprehensive reviews to ensure errors are corrected, synergy among related documents, and final deliverables meet expectation.
• Keeps updated on the company guidelines and initiatives, and any applicable parties in the development of required documents.
• Ensures that hardcopy and electronic reports are consistent and comply with required formats. Reviews data tables and listings and ensures that errors are corrected. 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 scientific documents for accuracy, formatting, consistency and compliance to protocols or SOPs.
• Works with senior staff to determine approach for new assignments.
• Keeps updated on the guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents.
• 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 2+ years') or equivalent combination of education, training, & experience.
• Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

• 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 abilities
• 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 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.