Manager, Pharmacokinetics (Edison)

Description

The Manager, Pharmacokinetics will be responsible for overseeing and managing pharmacokinetic (PK) studies in support of drug development programs within a generic and 505b2 pharmaceutical organization. This role requires a combination of technical expertise and leadership to ensure the successful planning, execution, and interpretation of PK studies. The individual will play a crucial role in regulatory submissions, ensuring alignment with global regulatory guidelines and compliance with company standards. The role involves working in a fast-paced, deadline-driven atmosphere with cross-functional teams.

Job duties :

Pharmacokinetic Study Design and Oversight :

• Design, plan, and oversee pharmacokinetic and bioequivalence studies from early clinical development to regulatory submission.
• Collaborate with cross-functional teams, including clinical, regulatory, and project management teams, to align study designs with overall program objectives.
• Provide scientific expertise and guidance for defining study parameters, data collection, and interpretation.

Regulatory Compliance and Documentation :

Data Analysis and Interpretation :

Leadership and Collaboration :

Continuous Improvement :

Minimum qualifications :

Preferred qualifications :

Padagis Core Competencies :

Since its beginning, Padagis has been undergoing the process of identifying what we believe will lead to the success of our organization in a competitive landscape. To that end, we have developed a set of five core competencies. We strive to bring employees on board the journey with us who exemplify these key competencies :

About us :

At Padagis our focus is on health care products that improve people's lives. We are a market-leading generic prescription pharmaceutical company that specializes in extended topical medications, like creams, foams, mousses, gels, liquids and inhalable products. It's a great time to join our team because we have a high growth trajectory with now more than 1,300 employees across six locations in the United States and Israel. We've already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system. Our team members work in a dynamic environment where opportunity is built on a foundation of honesty and transparency. Please consider joining our team where great things are happening and you can make a difference.

What's Next :

At Padagis a real recruiter AND the hiring manager will review your application, not just a bot. This means we pay special attention to each application submitted for the position. While it could take a couple of days for us to get back with you, please know that we appreciate you applying for the open position and ask that you monitor your email for updates.

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