Senior Manager, Medical Writing Job at Teva Pharmaceuticals USA in West Chester

Senior Manager, Medical Writing

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 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.

Travel Requirements: International and domestic Location: US-Based Remote (US Eastern time zone preferred)

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 minimum 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.

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.

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all.