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Form of work
SalaryJob Description
Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
Discover Impactful Work:
The Scientific Writer 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.
A day in the Life:
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, 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 environements
Working knowledge of analytical laboratory procedure
Effective written and oral communication skill
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
Physical Requirements / 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 lift and move objects up to 25 pounds.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
