Sr Reg Intelligence Associate/Consultant (Project Management) at Syneos Health Clinical Solutions

Job responsibilities

• Gather new regulatory information through routine surveillance of agreed regulatory sources.
• Reviews surveillance alerts and queries and determine actions to be taken.
• Conduct regular annual country review of regulatory source documents for the clinical regulatory intelligence.
• Support ad-hoc research requests from the business and gather regulatory information for potentially new topics.
• Interacts with internal experts to collect country and region-specific regulatory intelligence.
• Conducts searches within commercial Regulatory Intelligence databases to find regulations and guidelines relevant for clinical regulatory intelligence.
• Identifies and responds appropriately to issues and problems, providing innovative and effective solutions.
• Recommends and support implementations of enhancements of Syneos Health Regulatory Intelligence processes to maintain the Regulatory Intelligence System.
• Manage translation requests of regulations and guidelines.
• General team organization tasks (internal meetings, follow-up activities etc.)
• Undertake department activities including departmental metrics, MS Teams and SharePoint updates.
• Maintains overall awareness in the field of regulatory intelligence as well as applicable regulatory requirements by reading related literature, attending training classes, attending professional meetings, etc. 
• Other tasks as needed.

Qualifications

What we’re looking for

• BA / BS in life sciences, regulatory intelligence, regulatory affairs, regulatory operations or related field required or regional equivalent or equivalent combination of education and experience.
• Experience in a work-related area preferred. 
• Ability to analyze information across multiple sources and manage large amounts of details.
• Strong research skills needed to support routine surveillance activities to detect, monitor, and synthesize complex regulatory information.
• Ability to interact with stakeholders from multiple departments at different seniority levels.
• Ability to work independently and to understand and conduct detailed instructions.
• Strong written and oral communication skills 
• Excellent problem solving and decision-making skills.
• Fluent in speaking, writing, and reading English.