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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

_This is a fully remote role supporting our GMP Lab in Middleton, Wisconsin. We welcome applicants 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. 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.

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.

Summary:

Assists in the preparation and review of scientific documents under general supervision to meet or exceed quality standards. Writes and edits basic to moderately complex analytical methods, reports and protocols for potential submission to regulatory authorities.

Responsibilities:

+ Prepares and/or assists in the preparation of scientific documents such as methods, protocols, reports, method development summaries, analytical methods, SOPs, client correspondence and other similar documentation.

+ Compiles laboratory data into a specified report format. 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.

Education and Experience:

+ 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.

Knowledge, Skills and 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

Work 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.

+ May require travel. (Recruiter will provide more details.)

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability** **Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.