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 firstname.lastname@example.org.