Sr. Document Quality Reviewer in Bedminster Township, NJ at Apex Life Sciences

Date Posted: 7/11/2018

Job Snapshot

Job Description



This position will be responsible for document Quality Control (QC) destined for regulatory submission, including clinical protocols, protocol amendments and study reports, Investigational New Drug Applications (INDAs), Statistical Analysis Plans (SAPs), Investigator Brochures (IBs) and comprehensive 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.

ESSENTIAL FUNCTIONS:

  • Oversee all aspects of pre-published document quality within Clinical Development.
  • Act as a resource for medical writers regarding proper utilization of Companys style guides, document systems, managing and maintaining 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 or exceeding deliverable timeline requirements as determined by the project team.
  • 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.
  • 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.
  • Ensure clinical and regulatory documents follow appropriate regulatory standards.
  • Coordinate periodic routine reviews of controlled documents.
  • Assist in training of new Document Quality Reviewers on reviewing submissions most efficiently.
  • Maintain and report 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


MINIMUM REQUIREMENTS:

  • Education: Requires 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.
  • 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.

Skills/Competencies:

  • 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.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.