Due to continued growth, PPD is recruiting a Country Approval Specialist's for our Site Intelligence & Activation (SIA) department in Copenhagen. The Country Approval Specialist will manage the preparation, review and coordination of Ethics Committee and Regulatory submission in Copenhagen and will coordinate all activities to get investigational sites ready to enroll patients in our clinical trials.
Duties include: Preparation, reviewing and coordinating local ethics and regulatory submissions in alignment with global submission strategy Providing local regulatory strategy and advice Acting as a key contact on a country level for all submission related activities and provide oversight for projects Taking ownership of bringing qualified sites to the status of 'ready to enroll' Draft, review and track contracts, utilising your legal and commercial acumen. Work with global project teams to provide them with contract and legal support of a high calibre to meet tight deadlines. Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided Additional tasks in line with business and department needs Qualifications Bachelor's degree in a life science subject Regulatory and submission experience and a good knowledge of applicable local requirements. Basic medical/therapeutic area and medical terminology knowledge Excellent communication and organisational skills and a self-motivated, flexible and professional attitude. The ability to handle multiple tasks effectively, often within strict deadlines is essential. Fluent English and Danish language skills. The successful candidate can look forward to job stability with a leading CRO that has experienced year-on-year growth. With future expansion plans, there is the opportunity to progress in your career with PPD. This position will be office based in our office in Copenhagen.