Analyst 2 - Quality Systems Document

Basic responsibilities

• Administer the approval process of research protocols using PUBSTRAT, including basic quality control, according to standardized procedures.
• Administer the approval process of scientific publication submissions using PUBSTRAT, including basic quality control, according to standardized procedures.
• Maintain entries into research process trackers and summarization of information for reporting to senior leadership.
• Assist in the development and updating / maintenance of PUBSTRAT administrator's process guidelines.
• Serve as main point of contact with the vendor of the PUBSTRAT platform.
• Document Preparation : memorandums, correspondence, and / or presentations as needed.
• File management (, Microsoft Teams, SharePoint, Word, Adobe)
• Assist in the critical review and proofreading of standardized process documents.
• Assemble relevant data, generate reports, compile statistics or information as directed (as needed)
• Conduct debarment / exclusion checks.
• Assist in development and maintenance of training curricula in ComplianceWire.
• Flexibility to accommodate a changing work schedule and sensitivity to international time zones is required.
• Develop in-depth knowledge of department’s research processes, policies, and procedures.
• Acquire knowledge of department organizational structure.
• Collaborate with administrative staff colleagues to ensure office efficiencies.
• Maintain J&J Credo objectives.
• Assist with Purchase Order requests and processing.
• Provide other administrative support as assigned by the Associate Director.

Qualifications

• A minimum of an associate degree is required. A bachelor’s degree is preferred.
• Experience with publication management systems (, PUBSRAT, PubPro) is highly preferred.
• Basic understanding of research methodologies (in clinical / health preferred)
• Knowledge in regulatory and / or compliance in health care industry (, clinical research, trials, health outcomes research) is highly preferred.
• Basic understanding of scientific publication methodologies preferred.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook, Adobe) is required.
• Ability to learn specialized computer (or Web-based) software used for document approval processes, training curricula, and other applications.
• Prior experience with creating standardized operating procedures is preferred.
• Must have excellent time management skills.
• Must have good verbal and written communication and interpersonal skills.
• Must have strong organizational skills, along with excellent judgment and reasoning abilities.
• Must be a strong team player with the ability to coordinate with other HEMA associates and research partners.
• Ability to multi-task and work under minimal supervision, in a dynamic, fast-paced, multicultural, international environment is required.
30+ days ago