Documentation Analyst - Proofreader

Piper Companies - Durham, NC

Full-time
Piper Clinical Solutions is actively seeking a Documentation Analyst - Proofreader to join a well-established global medical device company. This position is onsite working Monday through Friday 9-5 in RTP.

Responsibilities for Documentation Analyst - Proofreader:
Read, review, and approve various documentation and send out any change requests.
Proofread all marketing, labeling, regulatory and packaging documentation including medical device labels, marketing materials, SOPs, and any other documentation to ensure all is FDA, EU MDR, and ICH compliant.
Coordinate with multiple departments including manufacturing, marketing, executive management, labeling, regulatory affairs, quality assurance and engineering.
Work with quality management systems (QMS) including document control and change control in regards to regulatory affairs.
Technical Requirements for Documentation Analyst - Proofreader:

Bachelor’s Degree in public health, English, biology or related field.
At least 1 years of experience proofreading various documentation.
Experience with regulatory agencies including FDA, ICH, and EMA within quality assurance or regulatory affairs preferred.
Prefer 1 year of experience working in a medical device or pharmaceutical environment.
Excellent written, verbal, communication, and organizational skills.
Compensation & Benefits for Documentation Analyst - Proofreader:

Compensation: $17-21/hour based on previous salary history and experience
Full Benefits: Medical, Dental, Vision, etc.
Qualified candidates please send resumes to Meg Smith at msmith@pipercompanies.com.