Medical Writer

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 Medical Writing Associate II, in Global Regulatory Medical Writing, writes and edits clinical regulatory documents. The individual provides basic-level guidance in the production of clinical research documentation used in drug development and product registrations.

How you’ll spend your day

• Primarily works at project level.
• Writes and edits clinical regulatory documents including study reports, protocols, briefing books, and other submission documents (e.g. aggregate reports, post authorization safety studies).
• Compiles, analyzes, and summarizes data from various sources.
• Conducts proofreading, editing, document formatting, and comment resolution.
• Ensures 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. 
• May participate in the preparation/revision of document templates and SOPs.
• May train and support medical writers or external vendors/contractors on document planning, processes, and content development.

Your experience and qualifications

• Bachelor's, Master's, MD, PhD, PharmD in life sciences (or other related field)   

• University degree with a minimum of 2+ years of relevant experience; advanced degree preferred.

• Experience with narratives, aggregate reports, and investigator brochures (IBs).

• 2+ years with an advanced degree preferred experience authoring protocols, clinical study reports, and submission documents.