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.