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.
Location/Division Specific Information
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. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
Discover Impactful Work:
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.
Keys to Success:
Education
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Experience
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.
Knowledge, Skills, Abilities
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
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 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.
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 a 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.
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