Qualifications:
Education and Experience:
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
12+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training
and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Mastery of English language (written and oral) communication skills as well as local language where applicable
Exceptional attention to detail and quality as well as outstanding editorial/proofreading skills
Accomplished interpersonal skills to work effectively in a team environment and act as a liaison with other departments
Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
Effective organizational, time management, and planning skills to create and follow timelines,conduct long-range planning, adapt to changing priorities and handle multiple projects
Professional negotiation skills
Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
Advanced, broad understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH
and other global regulatory guidelines; in-depth understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
Advanced understanding of medical terminology, statistical concepts, and guidelines
Outstanding analytical, investigative and problem-solving skills
Excellent understanding of budgeting and forecasting
Sharp executive presence and consultation and presentation skills
