Client Summary:

• Technology company focused on improving content management and operational efficiency for highly regulated industries
• Provides software solutions that help organizations streamline workflows, improve consistency, and reduce manual processes
• Combines automation, structured data, and advanced technologies to support scalable content operations
• Helps enterprise teams accelerate execution and improve collaboration across global environments
• Innovative platform company focused on modernizing complex documentation and information management processes

Position Responsibilities:

Pre-Sales and Sales Collaboration

• Partner with Account Executives to drive early-stage discovery and align capabilities with customer needs across labeling, CMC, clinical, safety, quality, and medical affairs.
• Independently deliver tailored solution demonstrations, technical walkthroughs, and business case development in collaboration with Product Marketing and Solutions Consulting.
• Serve as the technical and regulatory voice during deal cycles, helping reduce friction in InfoSec, IT, and Procurement reviews.

Technical Architecture & Readiness Scoping

• Lead early architecture design sessions to map integration, content reuse, structured authoring, and metadata alignment strategies.
• Support proof-of-concept or sandbox efforts by configuring and demonstrating platform workflows that address client-specific use cases.
• Partner with Customer Success teams to assess readiness and define early implementation scope, particularly for large enterprise programs.

Cross-Functional Engagement

• Participate in global workshops, industry events, webinars, and customer advisory activities as a subject matter expert.
• Track deal progression, surface technical blockers, and collaborate with Engineering and Product to ensure roadmap alignment.
• Lead RFP/RFI responses. Assist in InfoSec reviews, and validation documentation across regulated content workflows.

Experience & Skills:
Required Experience and Qualifications:

You'll have some or all of these technical skills, experience and knowledge

• 7–12 years in one or more of the following roles:
• Solution Consulting or Sales Engineering for B2B SaaS
• Regulatory Information Management or Digital Transformation within pharma
• Technical product management or implementation consulting
• Proven experience working with structured content platforms and/or traditional content management systems such as Veeva, OpenText, CARA is desirable
• Demonstrated success supporting large, global clients with complex regulatory and operational requirements
• Strong storytelling, communication, and executive presentation capabilities
• Comfortable leading both strategic discussions and technical validations
• Skilled in quickly configuring platform instances based on customer technical requirements, creating custom workflows that demonstrate structured content authoring, metadata management, and regulatory compliance automation based on best practice strategies.
• Able to translate complex features into commercial, regulatory, and operational value
• Adept at managing multiple workstreams and communicating across cross-functional teams

Regulatory & Technical Knowledge

• Deep understanding of life sciences regulatory frameworks, including GxP, eCTD, IDMP, 21 CFR Part 11, and EMA/FDA guidance
• Strong knowledge of FHIR (Fast Healthcare Interoperability Resources) standards as applied to pharmaceutical regulatory contexts, including electronic Product Information (ePI), ICH M11 technical specifications, M4Q(R2) Quality implementation, and PQI/PQ-CMC data exchange formats
• Deep understanding of metadata modeling, ontology design, and taxonomy frameworks; ability to architect solutions that leverage controlled vocabularies, semantic relationships, and structured data to enable intelligent content reuse and automated compliance validation
• Proficient in building, configuring, and managing RESTful API transactions between enterprise SaaS platforms, with demonstrated ability to interpret technical specifications and API documentation to create Proof-Of-concept integrations; able to navigate and troubleshoot JSON, HTML and XML structures
• Ability to create and manage custom scripts, write Proof-Of-Concept level code using popular scripting and development tools, example: Python, JavaScript, HTML/CSS etc.
• Familiarity with AI/ML enablement in pharma workflows a strong plus; must be able to learn and quickly incorporate AI strategy, technology and vision into demonstrable solutions
• Strong understanding of information security (ISO 27001, SOC 2) and data privacy (GDPR, HIPAA)

We’re seeking these certifications or qualifications

• Bachelor’s degree required in a relevant discipline (e.g., Computer Science, Life Sciences, Regulatory Affairs, Information Systems).
• Preferred: Advanced degree (MBA, MS) or certifications such as RAC (Regulatory Affairs Certification), PMP, or TOGAF.
• Relevant technical certifications (e.g., AWS Certified Solutions Architect, SAFe, or similar) are a plus.
• Big 4 consulting or previous Pharma/Lifesciences IT transformation experience a plus

Compensation $220k, unlimited PTO and funded health benefits, including dental and medical.