Principal Medical Writing Domain Expert - Falcon
New
As a Work Anywhere company, we support your flexibility to work from home or in the officeFull-TimePrincipal
SalaryBase pay: $140,000 - $200,000. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.
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Job Details
- Experience
- 7+ years
- Required Skills
- Product ManagementGenerative AI
Requirements
- 7+ years of medical writing experience within pharma, biotech, or CROs.
- Heavy emphasis on authoring complex regulatory documents.
- Deep operational understanding of global regulatory guidelines (such as ICH E3).
- Expertise in complex clinical data mapping.
- Exceptional communication, presentation, and relationship-management skills.
- Comfort acting as a subject matter expert during commercial cycles.
- Passion for learning about agentic AI and generative technology.
- Adaptive and forward-thinking mindset.
Responsibilities
- Act as the visionary and 'Voice of the Customer' to guide product and engineering teams on platform architecture, source data mapping, and document logic.
- Define document generation frameworks to synthesize clinical data into regulatory-grade outputs.
- Establish objective quality criteria, review protocols, and verification frameworks to ensure regulatory compliance.
- Refine internal system instructions and content logic to handle document updates and complex clinical narratives.
- Participate in sales cycles to demonstrate expertise and build credibility with prospective buyers.
- Partner with early adopter companies to transition medical writing teams to human-in-the-loop review processes.
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