Job Description

Work Schedule Standard (Mon-Fri)
Environmental Conditions Office

Summarized Purpose:
Effectively reviews documents created within or outside of the company to ensure quality of a standard that meets or exceeds client's expectations. Documents include: regulatory submissions, integrated clinical study reports, serious adverse event narratives, study protocols and publications. Ensures integrity of data in tables against source documents. Instructs others outside of the quality review group on the review process.
Essential Functions

• Reviews highly technical documents of all types created within or outside of the company to ensure quality standard that meets or exceeds client's expectations.
• Verifies scientific logic and clarity of the document by verifying data in tables against source documents, checking for consistency according to current regulatory standards and guidelines.
• Edits for accuracy, consistency and grammatical correctness ?
• Adjusts schedule to accommodate unexpected requests for priority review.
• Revises scientific language for usage, flow, clarity, and audience appropriateness.
• Proactively queries authors to ensure compatibility with unique preferences and scientifically sound judgment
• Maintains, communicates and applies knowledge of current guidelines, templates and industry standards

Qualifications:
Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years').

Knowledge, Skills and Abilities:

• Should have Quality Review experience of CSR, Protocol, ICF, IB, IND Modules, and any other regulatory documents
• Capable of concentrating on the details of a document without losing sight of the overall objectives and intent of the document's message
• Good knowledge of the methods, techniques, and procedures of medical writing tasks
• Strong analytical ability
• Good working knowledge of medical terminology, statistical concepts, GCP, guidelines (e.g., ICH), and requirement of the FDA and other international regulatory agencies
• Detail oriented, thorough and methodical
• Proficient grammatical and communication skills, both oral and written
• Good organizational and planning skills
• Proven ability to work effectively in a team environment
• Advanced computer literacy and expertise
• Good understanding of document management systems
• Capable of working well under pressure and remaining motivated
• Capable of working both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment

Skills Required