Job Information
ThermoFisher Scientific Country Approval Associate in Copenhagen, Denmark
Job Description
Country Approval Associate / 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, e.g. 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.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.