Brief Description:

Under the direction of the Executive Director, Head of International Strategy, Publishing and Regulatory Excellence, the Senior Associate/Manager, Global Regulatory Affairs will support the Regulatory Policy, Intelligence and Library Services team through assisting the maintenance of the company’s digital literature collection, literature searching services and regulatory intelligence support.  

The role will also support research and development by enabling new and updating existing literature search policies, procedures, and work instructions.

Essential Functions/Responsibilities

• Support monitoring and curation of emerging regulatory intelligence including identification of key issues to the company.
• Support digital holdings collection by processing vendors and publisher renewals, agreements, acquisitions, through the company procurement system.
• Provide back up to the management of Drug Safety & Pharmacovigilance group’s weekly literature alerts.
• Support the creation and maintenance of digital library content, such as internal social media posts, e-newsletters, and website content. 
• Assist with data entry, reporting, and tracking statistics related to digital library usage and regulatory policy and intelligence trends.
• Participate in training and development activities to stay informed about new technologies and best practices. 
• Support regulatory teams in respect to submission copyright clearance as required.
• Help build and continuously improve regulatory intelligence systems and practices by refining, testing and implementing systems and process.
• Support development of training and outreach opportunities to promote digital knowledge resources across the company.
• Manage subscription access through Jazz portals including troubleshooting issues and technical maintenance. Monitor and maintain the library's digital systems, ensuring their functionality and user experience. Support literature search queries and literature alerts.
• Create new and update existing literature search policies, procedures and work instructions with accompanying training and support as required.
• Lead or contribute to other regulatory initiatives as required.

Required Knowledge, Skills, and Abilities

• Experience working in an academic or corporate environment with an international presence.
• Demonstrated professional or academic research experience using PubMed, Embase.com, Ovid, ProQuest Dialog, or similar databases to search for scientific/biomedical literature.
• Basic understanding of copyright laws and regulations.
• Proficiency with Microsoft Office 365, Sharepoint, and Endnote.

Required/Preferred Education and Licenses

• Bachelors degree in a relevant scientific or life sciences discipline required (or equivalent experience)
• Advanced degree and MLIS or related degree/certificate in Library/Information Science, or a combination of professional library or information science experience.