Teva Manager Medical Writing 

United States, New Jersey 

9813247

A Manager, in Global Regulatory Medical Writing, writes and edits clinical regulatory documents, including submission summaries and other complex documents, provides basic-level oversight and guidance, as well as resource management for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations.

Travel Requirements:International and domestic

US-Based Remote (US Eastern time zone preferred)

• Primarily works at project level.
• May oversee contingent workers and/or vendors; may provide training to others as needed
• Offers leadership and basic accountability, provide strategic assistance, and planning support for clinical regulatory documents.
• Writes and edits clinical regulatory documents, including submission summaries and other complex documents.
• Ensures that documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
• May participate in the preparation/revision of document templates.

Education/experience Required:

• PhD or PharmD with a minimum of 2 years of experience
• Master’s degree with a minimum of 4 years of experience
• Bachelor's degree with a minimum of 6 years of experience
• Knowledge of global regulations and guidelines for document submissions

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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