Careers at Frestedt Incorporated
Small but mighty.
CRQE Specialist I
General Purpose
To assist with Clinical, Regulatory, Quality and Engineering (CRQE) projects for pre-and post-market products and to complete specific projects while ensuring consistency with regulations, quality standards, commitments and goals.
Essential Functions and Responsibilities
- Project management including planning, implementation, prioritization, meetings minutes and data entry/analysis on behalf of clients to keep projects on time, high quality and within budgets
- Develop and execute on project requirements which may include:
- clinical research studies/clinical evaluation reports (CER)
- regulatory submissions
- quality management systems
- engineering reports
- Ensuring quality by following internal and external SOPs, Work Instructions and Forms/Templates for successful preparation of robust, high quality deliverables
- Read, analyze and implement regulations, standards and guidance documents (e.g. FDA, EU) relevant to client projects across multiple industries and disciplines
- Develop materials for on-line and in-person training (e.g. PowerPoint presentations)
- Conduct literature searches and communicate scientific content in a clear, concise manner
- Other duties as assigned
Qualifications
- Master’s Degree or PhD in a medical or science-related field or equivalent work experience
- At least 3 years clinical, regulatory, quality and/or engineering work experience
- Experience and qualification in project management
- Advanced computer skills with Outlook, Word, Excel, PowerPoint and other software tools
- Able to productively interact with Frestedt Inc. staff and client companies including corporate executives, research sites and research subjects
Requirements
- Must be focused, efficient, detail oriented and able to work independently
- Able to travel to client sites as needed (approximately 10% travel)
- Demonstrated ability to execute projects on time and on budget
- Must have excellent critical thinking and problem-solving skills
- Able to coordinate training sessions and to secure the required training documentation
- Able to reprioritize immediately as new projects arrive
- Passion for clinical research, regulatory, quality and engineering affairs activities for pharmaceutical, medical device and food industries
Interested applicants can send their resume and cover letter to info@frestedt.com with the CRQE Specialist I in the subject line.