Teva Director Therapy Area Head Medical Writing 

United States, Pennsylvania 

948610150

The Director, in Global Regulatory Medical Writing, may write and edit clinical regulatory documents, including submission summaries and other complex documents, provides a significant level of oversight and expert 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. The Director offers clear leadership and extensive accountability, strategic vision, and planning for clinical regulatory documents.

: 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 therapeutic area/functional level
• Likely to have direct reports; oversees contingent workers and/or vendors; provides training to others; strategically analyzes needs to manage resources and is accountable for resource allocation
• Oversees/mentors for all document types
• May write and edit clinical regulatory documents (all types)
• Ensures that documents include the proper context 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
• Leads/recommends the preparation/revision of document templates
• Participates in the recruiting/hiring process, and development of direct reports including identifying learning/training opportunities and executing development plans
• Responsible for tracking/providing metrics and established key performance indicators

• PhD/PharmD with a minimum 8 years experience or a Master’s with a mnimum of 10 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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