Teva Senior Manager Medical Writing 

United States, Pennsylvania 

718618117

The Senior Manager in Global Regulatory Medical Writing writes and edits clinical regulatory documents, including submission summaries and other complex documents. They provide intermediate-level oversight and guidance, as well as resource management for direct medical-writing support in producing clinical research documentation used in drug development and product registrations.

: International and domestic

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Primarily works on the product/program level.
• Possible to have direct reports; possible to oversee contingent workers and/or vendors; likely to provide training to others; and analyzes needs to manage resources.
• Offers leadership and fundamental accountability, provides strategic supervision, and planning assistance for clinical regulatory documents.
• Writes and edits clinical regulatory documents (all types).
• 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.
• Participates in the preparation/revision of document templates.

• PhD/PharmD with a minimum 4 years experience or a Master’s with a mnimum of 6 years experience
• Mastery of Microsoft Word
• Advanced regulatory medical writing expertise, strong writing/editing skills, knowledge of drug development regulations
• 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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