Summarized Purpose: Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services.
Supports the preparation of documentation and submissions under guidance.
Coordinates and manages client deliverables supporting regulatory compliance.
Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting.
Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.
Assists in business development and pricing of projects for the department.
Evaluates client needs in relationship to overall project timelines, quality and delivery.
Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed.
Experience in the preparation of documentation and submissions under EUCTR guidance and tools like RIMS, Veeva, CTIS, CTMS etc.
Knowledge, Skills and Abilities:
Good English language (written and oral) communication skills as well as local language where applicable
Good attention to detail and quality as well as editorial/proofreading skills
Good interpersonal skills to work effectively in a team environment
Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects. Good negotiation skills
Capable of working independently with direction and exercising independent judgment
Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables
Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
Basic understanding of medical terminology, statistical concepts, and guideline
