Country Approval Spec

Work Schedule
Other

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.

• Prepares, reviews and coordinates, under guidance, local regulatory submissions MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provides, under mentorship local regulatory strategy advice (MoH &/or EC) to internal clients.
• Provides project specific local SIA services and coordination of these projects.
• May have contact with investigators for submission related activities.
• Key-contact at country level for either Ethical or Regulatory submission-related activities.
• Coordinates, under mentorship, 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.
• Achieves PPD's target cycle times for site.
• May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
• May develop country specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
• Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
• Preferred experience in CRO / regulatory field.

• Effective oral and written communication skills
• Excellent interpersonal skills
• Strong attention to detail and quality of documentation
• Good negotiation skills
• Good digital literacy and the ability to learn appropriate software
• Good English language and grammar skills
• Basic medical/therapeutic area and medical terminology knowledge
• Ability to work in a team environment or independently, under direction, as required
• Basic organizational and planning skills
• Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations