Note: The job is a remote job and is open to candidates in USA. Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. The Principal Medical Writing Domain Expert will guide product and engineering teams to design an advanced regulatory authoring system, ensuring it meets global regulatory expectations while leveraging AI technology.
Responsibilities
- Help build your dream AI enabled Authoring Platform: Act as the ultimate visionary and "Voice of the Customer," guiding product and engineering teams on how an ideal, advanced authoring system should handle source data mapping, document logic, and summary execution
- Define Document Generation Frameworks: Go beyond static templates to map out how clinical data should be logically synthesized into regulatory-grade documents—starting with clinical trial results and scaling to broader regulatory submissions
- Define "What Good Looks Like": Establish objective quality criteria, review protocols, and verification frameworks to ensure the platform's initial and future outputs meet stringent global regulatory expectations
- Direct Content Instructions: Inform and refine the internal instructions and content logic used by the system to generate content, ensuring it captures the nuances of cyclical document updates and complex clinical narratives
- Commercial & Sales Enablement: Actively participate in the sales cycle. Meet with prospects, demonstrate profound medical writing expertise, and build immediate credibility with prospective buyers
- Change Management Advisory & Early Adoption: Partner with early adopter companies to help their medical writing teams transition from manual drafting to a strategic, human-in-the-loop review process, acting as their internal champion to our product team
Skills
- 7+ years of medical writing experience within pharma, biotech, or CROs, with a heavy emphasis on authoring complex regulatory documents
- Deep operational understanding of global regulatory guidelines (such as ICH E3) and complex clinical data mapping
- Exceptional communication, presentation, and relationship-management skills, with total comfort acting as a subject matter expert during commercial cycles
- A passion for learning about agentic AI and an adaptive, forward-thinking mindset regarding how generative technology can transform regulatory document workflows
- Prior experience collaborating directly with software vendors or innovation teams to develop or optimize medical writing technology solutions
Benefits
- Medical, dental, vision, and basic life insurance
- Flexible PTO and company paid holidays
- Retirement programs
- 1% charitable giving program
Company Overview
Company H1B Sponsorship