Sr Document Review Spec

Work Schedule

Environmental Conditions

Summarized Purpose:

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