Job Information
Job Description
Responsible for conducting gap analyses on existing SOPs and prepare new SOPs. Minimum qualifications include:
- A minimum of five years experience with GCP practices and processes
- Experience writing SOPs for CROs, biopharmaceutical, medical device, or nutraceutical companies
- A solid understanding of Clinical Research principles and expertise in FDA GCP regulations/guidances and ICH GCP Guidelines
- Experience with flow charting processes for writing effective procedures
- Ability to travel to occasional client meetings, if needed
- Effective interpersonal skills; ability to work with all levels of personnel
- Exceptional written communication skills
- Effective communication skills; ability to communicate issues accurately and precisely
- Attention to detail, accuracy, completeness, and timelines
- Strong Microsoft Office skills
- Ability to multi-task
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