Sr. QC Reviewer - Medical Writing FSP
100% Remote | Must be US based
Join our FSP Medical Writing team as a Sr. QC Reviewer, providing dedicated support to a single sponsor. This is a salaried, full-time role with benefits including medical, dental, life, disability, paid holidays, vacation time, 401K and more.
MUST HAVE
- BS in Life Sciences (MS preferred)
- Medical Writing Professional w/background in Pharma/Biotech/CRO
- Hands on QC of Clinical/Regulatory documents with significant experience reviewing Clinical Protocols is critical
location: Telecommute
job type: Outsourcing Project
salary: $85,000 - 100,000 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- The primary role of the Sr. QC Reviewer is to perform scientific quality review of regulatory documents to ensure date integrity and compliance with applicable regulatory requirements.
- Perform quality reviews of global regulatory documents and submissions including: clinical study reports (CSR), CSR appendices, CSR amendments, synopses, patient narratives, statistical analysis plans, investigator brochures, protocols, amendments, Investigational Medicinal Product Dossiers (IMPDs) and Common Technical Documents (CTDs) for content and data accuracy with sources
- Ensure the all documents meet designated requirements for formatting, consistency, grammar, style guidelines and publishing guidelines.
- Fact check referencing source documents when needed
qualifications:
- Bachelor's Degree required (nursing or scientific degree pre
- Master's Degree preferred in Medical/Scientific field
- Understanding of the pharmaceutical drug development process
- Must have Quality Control experience in the Medical Writing field
- Working knowledge of ICH and CFR regulatory guidelines
- High proficiency with Windows based applications and medical/scientific publication databases/resources
- Ability to manage multiple priorities and meet deadlines
- Excellent organizational and time management skills
- Strong oral and written communication skills
- Team player with excellent interpersonal skills
*LI-AT1
skills: Editing, QC Review, Clinical Study Report (CSR), Protocol and Protocol Amendment Writing, Common Technical Document (CTD), Version Control and Document Tracking
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
