Lyndsey Dorough

MBA

Project Management

Organizational Leadership

Avanir Pharmaceuticals

Medical Affairs Operations Specialist

• - Planned and executed drug development activities between Avanir and vendors for assigned projects while assuring a timely delivery of products for clinical studies • - Identified technical and resource issues while taking action, if needed, to prevent delay in decisions and timelines. • - Work resourcefully and analytically in a problem-solving environment while demonstrating teamwork, innovation, and excellence. Maintain effective communication with corporate officers and regional partners • - Planning and preparation of regulatory applications documentation, and interactions with internal regulatory affairs department to discuss issues and respond to inquiries. • - Provide an operational and technical expertise to manage product development, contract manufacturing, and analytical development for the company’s pharmaceutical products and support for departmental policy, procedure, and projects. • - Assess and communicate CMC requirements to ensure all clinical activities follow applicable regulations and guideline. • - Author and ensure compliance of company SOPs, protocols, and specifications to create more efficient procedures to be used in reference among company employees and contractors. • - Participate in investigation of non-compliance issues • - Conduct training to educate company employees of the quality systems, process developments and improvements.