Job description

Remote

Initially 3 months, with 6-month renewals

8 hours a day, core business hours 9-3 CST

Prepares technical documents to support both domestic and international regulatory submissions. Incorporates text, graphs, charts, tables and statistical analysis. Proofreads, circulates, edits, assembles, inspects and duplicates product submissions. 3-5 years exp. Requires a Clinical Background

What are the top 5 skills/requirements this person is required have?

• Experience in QC of regulatory clinical documents (Investigator Brochures, Clinical Study Reports, Protocols, etc.)
• Attention to Detail
• Ability to manage competing priorities
• Work in a team environment
• Strong communication skills

What years of experience, education, and/or certification is required?

• Bachelor’s degree required. 2-3 years relevant experience in QC of clinical regulatory documents or related experience.

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? Bachelor’s degree in science preferred.

What is the environment that this person will be working in (i.e. group setting vs individual role)? Independent and working as a team.

What positions/background experience do you feel are successful in this role: Authoring of regulatory clinical documents (Investigator Brochures, Clinical Study Reports, Protocols, etc.) and/or QA auditing positions

Job Type: Contract

Salary: $40.00 - $51.30 per hour

Benefits:

• 401(k)

Schedule:

• 8 hour shift

Experience:

• QC Review: 2 years (Required)
• Writing skills: 3 years (Required)

Work Location: Remote

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