We are looking for a Sr. Document Quality Reviewer, working in the Pharmaceuticals & Medical Products industry in Bedminster, New Jersey, United States.
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 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.
We are offering Competitive Compensation and Benefits.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Atleast 5 years of relevant experience (preferably reviewing pharmaceutical clinical research regulatory dossiers)
Experience reviewing clinical protocols and study reports and NDA documents (such as Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), Clinical Overview, Summary of Clinical Safety, and Summary of Clinical Efficacy) required.
Excellent written and verbal communication skills.
Attention to detail, with ability to perform a full quality check of a document within an aggressive timeframe.
Word processing skills, as well as significant knowledge of working processes within document management systems.
Good Clinical Practices (GCP) experience is a requirement.
Clinical Quality Compliance experience is a requirement.
Experience managing document quality control processes.
Proven experience with verifying clinical and nonclinical data.
Proven track record with regard to the preparation, development, and review of clinical documents in document management systems, using standard procedures is required.
Ability to adapt to rapidly changing organizational and business issues is required.
Broad knowledge and experience working in the GCP regulated clinical research arena, including a working knowledge of clinical methodologies, as well as the content, organization, and format of clinical research/regulatory documents.
FDA Good Laboratory Practice (GLP), current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) a plus.
Requires a Bachelor level degree in a life science or scientific communications field
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.