Description:
- Regulatory Affairs Labeling Associate Level - II is needed to support Client' business to prepare and review drug product regulatory labeling deliverables based on Reference Listed Drug labeling, FDA Guidance, regulation and Client internal practices.
- Support labeling review process with a Quality Assurance and data integrity mindset. Apply team concept to get things done and work collaboratively with everyone with transparency.
- Applying strategic thinking, pharmaceutical educational knowledge, and regulatory intelligence during preparation and review.
- Utilizing technical skills for learning new features and /or applications software which can support preparation and review activities.
Qualifications:
- Bachelor's or Associate's degree in a scientific or English discipline.
- Bachelor's degree + a minimum of 1 -3 years in the pharmaceutical industry with 1 of those years working with labeling, conducting reviews; OR
- Associate's degree + a minimum of 3-5 years pharmaceutical industry experience working with labeling, conducting reviews.
- Pharmaceutical Experience, worked in control environment to follow process, quality focus.
- An effective communicator and can work independently and collaboratively with everyone
- Having generic labeling experience is a plus.
Benefits: Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics. Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st. Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification. Synectics is an equal opportunity employer.