Job Title: Sr. Document Quality Reviewer/Quality Review Specialist
Location: Work from home
Contract length: 1 year
Client: Global Pharamaceutical Company
This position will be responsible for document Quality Control (QC) for regulatory submission documents including:
- Clinical protocols
- Protocol amendments and study reports
- Investigational New Drug Applications (INDA's)
- Statistical Analysis Plans (SAPs)
- Investigator Brochures (IBs)
- New Drug Application (NDA) documents such as clinical safety and efficacy summaries.
In addition, this position includes proof-reading and editing of documents in Microsoft Word "Track Changes" mode to ensure internal consistency, as well as consistency with source documents, Company SOPs, FDA regulations and ICH GCP Guidelines.
* Oversee all aspects of pre-published document quality within Clinical Development.
* Act as a resource for medical writers regarding proper utilization of Company's style guides, document systems, managing and maintaining MW SOPs and document templates, work to establish and improve process flows.
* Ensure the appropriate level of QC is planned and executed within each document review lifecycle (all drafts through final document), while also meeting deadlines.
- Perform 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). * Generate a clearly written QC report documenting all findings following each QC document review, and within the required timeframe. * 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. * Ensure clinical and regulatory documents follow appropriate regulatory standards. * Coordinate periodic routine reviews of controlled documents. MINIMUM REQUIREMENTS: Education: a Bachelor level degree in a life science or scientific communications field with at least 5 years of relevant experience (preferably reviewing pharmaceutical clinical research regulatory dossiers).
Experience: Minimum of 5 years related industry experience preferred. 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. Preferred Skills/Qualifications: 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.
- 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.
Sthree US is acting as an Employment Business in relation to this vacancy.