Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Location: Home-Based
Working Shift: Monday - Friday, 8AM-5PM EST
A COVER LETTER IS REQUIRED IN ORDER TO BE CONSIDERED FOR THIS ROLE
We are currently seeking an Associate Scientific Writer with a track record of excellence and experience to join our team at Thermo Fisher Scientific Inc. As a global leader in serving science, Thermo Fisher Scientific is dedicated to enabling our customers to make the world healthier, cleaner, and safer. With a team of over 100,000 colleagues, we strive to uphold our shared values of Integrity, Intensity, Innovation, and Involvement, working collaboratively to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.
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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.
What makes this opportunity truly exceptional is the chance to contribute to world-class research in a dynamic and ambitious environment. As Associate Scientific Writer, you will play a crucial role in communicating scientific data to our clients. Your organizational and writing skills will be instrumental in providing quality deliverables to our clients in support of drug development.
Responsibilities:
- Prepares and/or assists in the coordination and preparation of scientific documents under direct supervision to meet or exceed quality standards.
- Writes and edits scientific documents such as analytical methods, method development summaries, reports, and protocols and ensures compliance with required formats and SOPs for potential submission to regulatory authorities.
- Compiles laboratory data into a specified report format. Reviews data tables 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, and eCTD policy.
- Reviews scientific documents for accuracy, formatting, consistency, and compliance to protocols or SOPs.
- Keeps updated on the guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents.
Requirements:
- Bachelor's degree, or equivalent experience.
- Exceptional command of written and spoken English.
- Strong attention to detail and ability to maintain scientific rigor.
- Proficiency in scientific software and databases.
- Experience in scientific writing strongly preferred.
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:
- Good working knowledge of scientific terminology, medical, pharmaceutical, and research concepts
- Good knowledge of word processing, spreadsheets, table and graph generation, and use of applicable computer software
- Working knowledge of industry regulations, ICH or other regulated environments
- Working knowledge of analytical laboratory procedures
- Effective written and oral communication skills
- Detail oriented
- Time management skills
- Good editorial and proofreading skills
- Good problem solving and troubleshooting abilities
- Ability to work well in a collaborative team environment
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.