R&D Compliance Documentation Manager
Country : USA
State : New York
County : Suffolk County
Town : Melville
Category : Consulting - Audit
Contract type : Permanent
Availability : Full time
- Decision Making - Lead a team of employees that Compile Cross Functional Data required documents to support product launch. Attend meetings and provide status and guidance. (75%)
- Process Efficiency/Improvements- (20%) - Investigate new or existing tool to build efficiency in the current process, update systems and policies to align
- Problem Solving (25%) - Identify gaps and provide support to proactively alleviate potential snags in the process.
- Specialized experience in the development work needed to commercialization regulated products
- Strong cGMP knowledge specifically OTC, FDA, Commercialization
- Ability to guide team and ensure standards are followed
- Ability to collaborate effectively with teams outside of R&D
- Must have excellent communication skills (Written & Verbal).
- Ability to work nimbly, and have strong problem solving skills
- Strong organization skills
- Microsoft office skills.
- Detail oriented, superior review skills -7 Years Minimum Experience