Who we are

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

A Senior Manager, in Global Regulatory Medical Writing, writes and edits clinical regulatory documents, including submission summaries and other complex documents, provides intermediate-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. This is a remote opportunity.

Travel Requirements: International and domestic

Location: US-Based Remote (US Eastern time zone preferred)

RELOCATION ASSISTANCE IS NOT AVAILABLE

WORK VISA SPONSORSHIP AVAILABLE

How you’ll spend your day

• Primarily works on the product/program level
• 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

Your experience and qualifications

• Bachelor's degree in life sciences or related scientific discipline with at least 8 years of pharmaceutical industry regulatory writing experience. (CSRs, protocols and IBs.)

Enjoy a more rewarding choice

We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.

Reports To

Therapy Area Head, Medical Writing

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