Sr. Scientific Writing Specialist

Title: Sr Scientific Writing Specialist

Location: REMOTE

Schedule: M-F Full Time

Type: Contract

Responsibilities:

Help with drafting and handling reviews of submission documents for nonclinical pharmacology. In this exciting role you will prepare eCTD tabulated and written summaries, nonclinical pharmacology study reports, and participate in comment reconciliation.

Independently author nonclinical documents for submission to health authorities worldwide

Participate in the revision and maintenance of document templates or shells

Adhere to timelines for document preparation

Abide by and keep current with GxP and regulatory guidelines and all company SOPs or working practices pertinent to the position

Simultaneously advance multiple projects as assigned

Requirements:

BS with 5-7 years or a MS or PhD with 0-2 years of scientific writing experience (PhD preferred)

Computer proficiency (Word, Excel, Adobe, and related software)

Fluency in the English language is required.

Basic understanding of the eCTD and the drug development process is a plus, as is GLP experience

Have Computer proficiency (Word, Excel, Adobe, and related software) and fluency in the English language is required

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.