Principal Medical Writing Domain Expert - Falcon

Veeva Systems, Inc.; Boston (MA); Hybrid; USD 140,000 - 200,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Flexible PTO

Paid holidays

Retirement program

Charitable giving

Job summary

Veeva Systems, Inc. seeks an elite Medical Writer to serve as Principal Medical Writing Domain Expert for Veeva Falcon, guiding advanced regulatory authoring with a focus on absolute data fidelity and narrative quality.

You will lead product and engineering collaboration to design an AI-enabled platform that automates primary clinical documents while scaling across global regulatory assets, ensuring compliance with ICH guidelines and regulatory expectations.

Qualifications

• 7+ years of medical writing experience within pharma, biotech, or CROs with emphasis on regulatory documents.
• Deep understanding of global regulatory guidelines like ICH E3 and complex clinical data mapping.
• Excellent communication, presentation, and stakeholder-management skills.
• Passion for learning agentic AI and applying it to regulatory workflows.

Responsibilities

• Help build an AI-enabled authoring platform by guiding data mapping, document logic, and summary execution.
• Define document generation frameworks from clinical trial data to regulatory submissions.
• Establish objective quality criteria, review protocols, and verification frameworks for outputs.
• Direct content instructions to capture cyclical updates and complex narratives.
• Participate in commercial cycles, meet prospects, and demonstrate medical writing expertise.
• Advise on change management and help early adopters transition to human-in-the-loop review.

Skills

Medical writing experience

ICH E3 knowledge

Communication skills

AI / generative tech interest

Job description

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

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 below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.

Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at [e-mail].