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

An Associate Director, in Global Regulatory Medical Writing, may write and edit clinical regulatory documents (all types), 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.

Travel Requirements: International and domestic

*** US-BASED REMOTE POSITION ***

How you’ll spend your day

• Primarily works on the multiple product/program level
• Manages direct reports; contingent workers and/or vendors and provides training to others
• Strategically analyzes needs to manage resources. Manages/mentors for all document types
• Writes 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 adheres to applicable regulatory guidelines and departmental and editorial standards
• Leads/recommends the preparation/revision of document templates
• Formulates strategy under guided supervision; demonstrates "big picture" perspective leveraging experience to recommend strategies
• Tackles difficult problems; makes decisions and troubleshoots in ambiguous situations
• Drives communication toward common understanding and actionable results; proficient in negotiation skills; and conceptualizes and leads initiatives within function
• Leads development of process, and preparation/revision of SOPs and guidance documents
• Manages and delivers assignments with quality and within timelines
• Provides input for budget planning
• Participates in the recruiting/hiring process, and development of direct reports including identifying learning/training opportunities and executing development plans

Your experience and qualifications

• PhD or PharmD in life sciences (or other related field), with a minimum of 6 years of experience

OR

• Master’s degree in life sciences (or other related field) with a minimum of 8 years of experience

Reports To

Therapy Area Head, Medical Writing

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