Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

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.

• Prepare, review and coordinate, under guidance, local regulatory submissions, additional special national local applications if applicable, e.g. gene therapy approvals in alignment with global submission strategy
• Provide, under guidance local regulatory strategy advice 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

• Bachelor's degree
• 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 negotiation skills
• 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