Principal Medical Writing Domain Expert - Falcon

Lifelancer Ltd; United States; Remote; USD 140.000 - 200.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision, and basiclife

Flexible PTO and company paid holidays

Retirement programs

1% charitable giving program

Zusammenfassung

Veeva Systems is seeking an elite Medical Writer to serve as our Principal Medical Writing Domain Expert for Veeva Falcon. This role will help design an AI-enabled authoring platform that preserves strategic messaging, narrative flow, and absolute data fidelity while automating primary regulatory documents.

You will guide product and engineering teams on data mapping, document logic, and quality controls, and participate in early adoption with health‑care partners, clinical research

Qualifikationen

• 7+ years of medical writing experience within pharma, biotech, or CROs, focusing on regulatory documents.
• Deep operational understanding of global regulatory guidelines (ICH E3) and complex clinical data mapping.
• Exceptional communication, presentation, and relationship-management skills, with comfort as a subject matter expert during commercial cycles.
• Passion for learning about agentic AI and how generative tech can transform regulatory document workflows.

Aufgaben

• Help build AI-enabled Authoring Platform: guide product and engineering on data mapping, document logic, and summary execution.
• Define document generation frameworks from clinical data to regulatory-grade documents, starting with trial results and scaling to submissions.
• Establish objective quality criteria, review protocols, and verification frameworks for global regulatory outputs.
• Direct content instructions to capture nuances of cyclical updates and complex narratives in the system.
• Participate in sales cycles, meeting with prospects and demonstrating deep medical writing expertise to build credibility.
• Partner with early adopters to drive transition from manual drafting to human-in-the-loop review with the product team.

Kenntnisse

Regulatory writing

Communication

Relationship management

AI in regulatory

Jobbeschreibung

Job Title: Principal Medical Writing Domain Expert - Falcon

Job Location: Boston, MA

Job Location Type: Remote

Job Contract Type: Full time

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company - we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

The Role

We are seeking an elite Medical Writer to serve as our Principal Medical Writing Domain Expert for Veeva Falcon. This is a rare opportunity to step away from repetitive manual drafting and help design the advanced regulatory authoring system of your dreams. You understand that the next generation of medical writing is AI enabled whilst preserving strategic messaging, narrative flow, and absolute data fidelity. In this high-impact role, you will bring your master-level expertise to bear, guiding our product and engineering teams to build a platform that automates primary clinical documents (such as CSRs and summaries) with total precision, before scaling across a comprehensive portfolio of global regulatory assets.

What You'll Do

• 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

Requirements

• 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

Nice to Have

• Prior experience collaborating directly with software vendors or innovation teams to develop or optimize medical writing technology solutions

Interviewing with Veeva

We value your time and believe in a transparent hiring process. Here is the process you can expect. Follow the application process and submit your resume. Within 3 days, you will receive a link to a personality assessment administered by a third party. Once you complete the assessment, our team will review your full application package and follow up via email with our decision. If moving to the interview stage, the process is as follows: A conversation with the hiring manager A practical case exercise A final conversation with our group's Senior Leader. Once all interviews are complete, the manager will be in touch with a final decision.

Perks & Benefits

• Medical, dental, vision, and basic life insurance
• Flexible PTO and company paid holidays
• Retirement programs
• 1% charitable giving program

Compensation

Base pay: $140,000 - $200,000 The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or b