GLOBAL LABELING STRATEGIST

Top 10 Pharmaceutical Company with a location in Plainsboro NJ is seeking a Global Labeling Strategist to join their team.

Compensation is commensurate with experience and education.

 

Requirements:
-Advanced degree (PharmD or PhD preferred)or Bachelor's degree and 3-5 years relevant experience.
-Ability to strategize labeling contribution to regulatory projects with direction from supervisor.
-Ability to assess situation with regard to appropriateness of working independently versus seeking guidance from supervisor.
-Understanding of regulatory agencies, industry practice, and the drug development process.
-Ability to handle multiple projects and prioritize/work independently.
-Ability to co-lead teams with the director/associate director to address complex (labeling) issues to develop plans of action and oversee completion.
-Ability to proactively share information with peers and generate discussion to resolve complex issues.
-Ability to assimilate clinical and scientific information, and present it in a concise manner.
-Either has or has the ability to acquire a general understanding of pharmacotherapeutics across therapeutic areas.
-Excellent technical skills and the ability to learn new systems and apply them practically.

Description:
Primary focus:
-assists Group Director or other supervisor with the content development process for revision of US Package Inserts (USPI) according to the January 24, 2006 regulations.
-coordinates labeling changes, development of text, and cross-functional review of the above documents.
-oversees the preparation by Labeling Operations of submission-ready labeling documents and composition copy for USPIs and packaging text.

Key Words:  Regulatory, Label, Package, Document, Global, PhD, New Jersey,