Content Review Specialist

The role of a Document Quality Specialist is crucial in ensuring that documents meet the highest standards of quality. This specialist reviews and edits documents to ensure they conform to client specifications, templates, style guides, and other relevant documents. They work closely with clients to establish clear expectations for project deliverables and provide leadership within internal review teams.

• Demonstrates strong proficiency in quality control review, including verification of document against source, internal consistency, grammar, and punctuation; trains others in this knowledge
• Expertly performs formatting techniques consistent with industry guidelines, including template utilization, style application, table insertion, figure creation, overall document appearance and function (i.e., creation of Table of Contents and cross references), and resolves document quality issues
• Publishes documents to regulatory health standards and learns requirements for submission-ready documents and the submission structure; has a basic understanding of the guidance that dictates the placement of documents in the submission; and can expand knowledge in document management or publishing related activities, depending on business needs:
• Provides effective leadership for all document quality-related tasks and services:
• • Leads document quality-related projects
  • Coordinates with all members of the project team to share project-specific information
  • Manages timelines and budgets
  • Communicates client feedback with the team
  • Provides strategic insight and proposes ways to improve performance on document quality-related tasks
  • Proactively and effectively manages budgets while communicating with key internal stakeholders
• Demonstrates clear and effective written and verbal communication, ensures actions align to applicable standard operating procedures, work instructions, and quality best practices; remains in compliance to training and position standards.
• Meets quality expectations and deliverables in daily performance; daily activities align with business and personal productivity goals; responds positively to feedback; and adjusts performance accordingly as well as proactively communicates opportunities for growth and learning to manager.
• Mentors more junior staff to become more proficient in quality control review, formatting, and/or publishing tasks
• Perform other duties as required by the business

• Bachelor's degree in English, journalism, scientific discipline, or related field with an interest in regulatory writing
• Editor in the Life Sciences certification desired, but not required
• Strong computer skills, including proficiency with Microsoft Office Suite (e.g., Outlook, Word, Excel, and PowerPoint) in terms of editing tools, creating and modifying tables, and inserting figures
• At least 2 years of prior related experience; highly skilled, talented, and motivated candidates will be considered
• Background in pharmaceuticals and/or science and technical industries is preferred
• Understanding of GXP, ICH E3, electronic Common Technical Document (eCTD), AMA style guidance and version control, and MS Word template
• Proven success in team-based environment

Skills & Abilities:

• Able to work in a collaborative environment and be tolerant of differences in culture and beliefs, easily build relationships with others, openly share information, and willingly contribute toward accomplishment of team goals
• Communicates clear, concise, and relevant information in an appropriate business format
• Able to be comfortable with some degree of ambiguity, easily build relationships with others, supporting all team members where possible
• Be action and detail oriented, always seeking new development opportunities to build knowledge and skills
• Demonstrates solid time management skills
• Shows flexibility to meet project needs as required by deadlines and meets corporate goals and objectives
• Possesses basic understanding in processes that impact the quality service line as well as short-term business/functional basics and goals, especially how it impacts project work, key drivers of success, and combines them to set priorities
• Able to recognize document quality issues and potential resolution; can troubleshoot standard document quality-related issues for internal and external teams
• Able to lead projects in support of one or more of the project-related activities, capable of generating project timelines, meeting agendas and minutes, schedule and lead project meetings with clients, communicating realistic expectations, and delivery of documents or services based on contract
• Participates willingly toward accomplishing group goals demonstrating respect for team efforts
• Demonstrates an ability to recognize various scenarios and knows when to proceed, when to determine consensus, and when to determine a new productive path forward
• Able to independently understand expectations for projects with a proactive approach and little need for detailed instructions, will look to senior members for guidance but will act independently based on previous experiences