Job Description

Role Description

This is a fully remote role supporting our GMP Laboratory in Middleton, WI. We welcome applications from all locations within the US.

• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.

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.

Our PPD™ Laboratory services GMP Lab team has a direct impact on improving patient health through the expertise of scientists, industry thought leaders and therapeutic experts.

Assists in the coordination and preparation of basic scientific documents under direct supervision:

• Responsible for preparing and editing scientific documents to meet or exceed quality standards.
• Assists in the design, preparation and review of analytical protocols for validation or analytical studies.

A day in the Life:

• 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.

Qualifications

• 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.
• 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.

Requirements

• 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.

Benefits

• 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.

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