Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline, works independently under limited supervision. Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects.
Responsibilities
- Acts as a Regulatory Advisor on complex clinical trial projects or programs
- Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.
- Prepares and maintains core clinical trial dossiers in accordance with applicable regulatory requirements.
- Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, Investigators Brochure, clinical trial justifications with minimum support of senior staff
- Interacts with internal and external clients to provide regulatory guidance and strategic input for clinical trials.
- May strategically plan and oversee global country submissions
- Can provide support on regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs)
- Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.
- Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA).
- Deliver regulatory training/presentations as required.
- Good understanding of the regulations, directives and guidance supporting clinical Research and Development
- Demonstrates comprehensive regulatory/technical expertise
- Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
- Strong ownership and oversight skills
- Demonstrated skills in chairing small meetings
- Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision
- Ability to propose revisions to SOPs or suggest process improvements for consideration
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
- Strong software and computer skills, including MS Office applications
- Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience* or high school diploma plus at least 9+ years experience* (*or combination of education, training and experience)
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- Travel will be required
