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CHANGE MANAGEMENT/REGULATORY FILING ASSISTANT WITH PHARMA EXP. (REMOTE) East Coast Hours. Required Skills:
- Associates or B.S. Degree in Engineering or Science field such as Integrated Science, Biology, Biological System Engineering, or related Life Science or Engineering Discipline.
- Minimum of 2 years in change management/execution experience and/or Regulatory filing experience.
- Experience working in a pharmaceutical or cGMP environment.
- Experience with project coordination.
- Excellent organizational skills.
- Excellent verbal and written communication skills; interpersonal and team skills; and collaborative skills.
- Technical writing.
- Consistent, strong personal character, ethics, and integrity.
- Strong desire to succeed and to help others to do the same.
- Robust problem-solving skills.
- Experience in change management systems.
- Experience with cGMP and/or Pharma.
- Experience working with a sterile process.
- The successful candidate will have the opportunity to apply his or her enthusiasm and technical skills as a member of a multidisciplinary team supporting new products and changes at varying levels of change management.
- The successful candidate will work to manage change management tasks and tracking.
- Supporting projects with particular emphasis on IPI and other change management systems.
- Supporting changes with varying levels of complexity.
- Supporting investigations and analyses to determine the root cause and impact.
- Achieving safety, quality, and environmental compliance excellence in all assignments.
- Producing high quality work against firm deadlines.