Responsibilities:
- Lead global project groups to obtain information needed to create global process documents.
- Plan for and manage reviews of new and existing processes and standards to ensure completeness, consistency, quality and compliance with established requirements.
- Manage document control and maintenance process for all Celerion processes and standards.
- Ensure processes and standards are compliant with regulatory requirements, corporate governances and the Quality Management System.
- Develop, coordinate and facilitate training programs for appropriate processes and standards.
Requirements:
- Bachelor's degree in Life Sciences or related degree preferred
- Excellent oral and written communication skills
- High proficiency in MS Office applications and Adobe Acrobat
- Excellent organization skills
- Strong facilitation, presentation and training skills
- Self-motivated and able to perform with minimal supervision
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Skills Required
- Bachelor's degree in Life Sciences or related degree
- Excellent oral and written communication skills
- High proficiency in MS Office applications and Adobe Acrobat
- Excellent organization skills
- Strong facilitation, presentation and training skills
- Self-motivated and able to perform with minimal supervision
What We Do
Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines. With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. Our operations are strategically located in: Lincoln, Nebraska (Corporate Headquarters) Philadelphia, Pennsylvania Phoenix, Arizona Belfast, Northern Ireland,UK Zurich, Switzerland Vienna, Austria Richmond, Virginia Montreal, Quebec, Canada For more information, visit: www.celerion.com
