Director, Therapy Area Head, Medical Writing - REMOTE (EST/CST)

Teva Pharmaceutical Industries•West Chester, PA

75d•Remote

About The Position

Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity 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. Travel Requirements: International and domestic Location: US-Based Remote (US Eastern time zone preferred)

Requirements

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

Responsibilities

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

Benefits

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
Life and Disability Protection: Company paid Life and Disability insurance.
Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
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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