Technical Writer / SOP Writer
- US Remote, United States
We’re over 1600 strong across the globe. We’re scientists, strategists, creatives, and innovators. We value individual brilliance and build a strong foundation for Teamwork across all our business. We love the challenge of our industry. We’re changing lives and redefining success every step of the way.
You are dynamic. You are curious. You are more than your job.For you, excellence isn’t just a word; it’s the measure for all you do. You’re passionate. Driven. Dedicated. You can’t stand mediocrity. And you might be the team member we're looking for.
Are you a skilled writer, ready to document SOPs and provide key information to clinical teams? Bring your wordsmithing excitement to PSI as a Technical Writer.
USA: Remote Position
The scope of responsibilities will include
- Responsible for creating, reviewing, and/or editing, SOPs, work instructions, templates/forms etc. to provide clear and correct guidance for clinical research processes and procedures
- Interview and confer with SMEs in cross functional groups develop and/or revise documentation content for completeness and consistency with the processes covered
- Standardize or make editorial changes to SOPs, Work Instructions, Templates/Forms, prepared by SMEs or other Company personnel
- Use Microsoft Word for editing and/or creating documents demonstrating proficiency with templates and custom formats
- Ensure verbiage is easy for comprehension across a population where English is not always the first language
- Review established documentation and recommend revisions or changes in format or technical language
- Provide direction with the use of best practices for documentation hierarchy during documentation creation process
- Maintain records and files of work and revisions
- Manage the documentation, change order, and change control processes of the procedures as this applies to the scope of responsibilities assigned/activities delegated
- Develop specific goals and plans to prioritize, organize, and accomplish objectives
- A Bachelor’s Degree is required, preferably with an educational background in science, engineering, manufacturing.
- Minimum 5 years of experience technical writing and/or procedure development, preferably in FDA regulated environment
- FDA regulated Manufacturing and/or Quality experience is a plus
All your information will be kept confidential according to EEO guidelines.