Sr. Document Quality Reviewer (Westwood)

Employment Type

: Full-Time


: Scientific Research

The Opportunity

We're looking for a Sr. Document Quality Reviewer, working in the Pharmaceuticals & Medical Products industry in Bedminster, New Jersey.

ESSENTIAL FUNCTIONS: Oversees all aspects of pre-published document quality within Clinical Development. Acts as a resource for medical writers regarding proper utilization of Companys style guides, document systems, managing and maintaining MW SOPs and document templates, work to establish and improve process flows. Ensures the appropriate level of QC is planned and executed within each document review lifecycle (all drafts through final document), while also meeting or exceeding deliverable timeline requirements as determined by the project team. Performs proof-reading and QC review of documents prepared by internal or contract medical writing staff (ie, cross checking the internal consistency of text between sections, as well as verification of relevant text against tables, figures and data listings etc., which may be either contained within or may reference external sources). Generates a clearly written QC report documenting all findings following each QC document review, and within the required timeframe. Evaluates the descriptions of scientific and clinical analysis for appropriate language. Ensures documents follow Companys writing conventions (follows internal style guide) and regulatory standards. Ensures the appropriate use of AMA style its application to clinical and regulatory documents. Ensures reviewer comments are incorporated or addressed appropriately. Checks documents for grammatical accuracy, punctuation, spelling, organization, internal logic, and consistency. Ensures clinical and regulatory documents follow appropriate regulatory standards. Coordinates periodic routine reviews of controlled documents. Assists in training of new Document Quality Reviewers on reviewing submissions most efficiently. Maintains and reports relevant performance and compliance metrics. Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.
Associated topics: clinical, food, histology, immunohematology, microbiological, microbiology, nutritionist, pharmacology, therapy, transfection

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