Country Approval Associate

1 month ago

København, Denmark Thermo Fisher Scientific Full time

/ Country Approval Specialist

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our Clinical Operations team in Denmark is expanding and we are currently looking for a Country Approval Associate (CAA) / Country Approval Specialist (CAS) who will be working from our office in Copenhagen or home based anywhere in Denmark.

Country Approval Associate (CAA) / Country Approval Specialist (CAS), you will:

Prepare, review and coordinate, under guidance, local regulatory submissions ((Danish Medicines Agency (MoH), Ethics Committee (EC) and EU CTR part II submissions), additional special national local applications if applicable, gene therapy approvals, IVDR/MDR) in alignment with global submission strategy Provide, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients Provide project specific local start up services and coordination of these projects Have contact with investigators for submission related activities Key-contact at country level for either Ethical or Regulatory submission-related activities Coordinate, under guidance, with internal functional departments to ensure various site start up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation Prepare the regulatory compliance review packages, as applicable Develop country specific Patient Information Sheet/Informed Consent form documents Enter and maintain trial status information relating to start up activities onto PPD clinical research services tracking databases in an accurate and timely manner Ensure the local country study files and filing processes are prepared, set up and maintained as per internal or applicable client SOPs Maintain knowledge of and understand company SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Keys to Success: Bachelor's degree or similar

0 - 2 years related experience or equivalent combination of education, training, & experience Effective oral and written communication skills Excellent interpersonal skills Strong attention to detail and quality of documentation Good computer skills and the ability to learn appropriate software Fluency in English and language spoken at local place of work Basic medical/therapeutic area and medical terminology knowledge Ability to work in a team environment or independently, under direction, as required Good organizational and planning skills Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulation

Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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