Sr Document Review Spec

Work Schedule

Environmental Conditions

Job Description

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.
• Ensures 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.
• Coordinates the work of team members and tracks the status of documents being reviewed.
• Mentors junior team members.
• May represent the department at meetings with clients.
• Contributes to the development and modification of the quality review process. Collaborates with the writer to manager alliance account(s)
• Delegates weekly assignments to the quality review team and fields questions as appropriate.

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:

• Capable of concentrating on the details of a document without losing sight of the overall objectives and intent of the document's message
• Thorough knowledge of medical terminology, statistical concepts, GCP, guidelines (e.g. ICH), and requirements of the FDA and other international regulatory agencies
• Familiarity with interpreting data and excellent analytical ability
• Effective oral and written communication skills
• Good organizational and planning skills
• Good interpersonal skills
• Ability to work on own initiative
• Good computer literacy and expertise
• Competent word processing skills
• Solid understanding of document management systems
• Suitable level of expertise within a broad range of medical writing projects
• Good knowledge of global and regional medical writing and regulatory affairs duties for clinical trials, marketing authorization and late-phase procedures
• Capable of providing general advice and training to others
• 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