Coordinator, Medical and Regulatory Affairs

Position Overview

The Coordinator for Medical and Regulatory Affairs plays a crucial role in supporting the diverse functions of the Medical and Regulatory Affairs Team, which includes Medical Affairs, Regulatory Affairs, Quality Assurance, Pharmacovigilance, and Medical Information. The ideal candidate will be proactive, detail-oriented, and possess excellent decision-making skills. This role requires a highly motivated professional with strong organizational and communication abilities, capable of working independently and prioritizing tasks to meet various departmental needs.

Key Responsibilities

• Provide comprehensive administrative support to the Vice President, including managing travel arrangements, calendar scheduling, expense reports, and coordinating meetings both on-site and off-site.
• Assist in managing functional budgets and provide administrative support for various team projects.

• Prepare and edit a range of documents, including correspondence, reports, presentations, and forms.
• Generate and analyze monthly ad-hoc reports, communicating findings effectively.
• Collaborate with the Finance department to manage invoices, prepare project approval forms, and reconcile monthly spending reports.
• Develop new reports to meet departmental needs and support the team with administrative tasks such as organizing, filing, and document management.
• Manage corporate and vacation calendars for the department.
• Engage with vendors and global colleagues as needed.
• Coordinate visitor reception and catering for in-house meetings and events.
• Handle incoming telephone calls, providing assistance, taking messages, or directing to the appropriate party.
• Verify translated documents, including letters, procedures, and agency documents.
• Report safety information, product quality complaints, and customer feedback in accordance with current procedures.

Qualifications and Competencies

• Previous experience in pharmaceutical administration is essential; experience in Medical and Regulatory Affairs is advantageous.
• 5-8 years of experience in a professional business environment.
• Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and Concur.
• Strong team player with the ability to work independently and demonstrate accountability.
• Excellent interpersonal, written, and verbal communication skills

Supervision

This position does not include supervisory responsibilities.