Certara Visa Sponsorship USA

INTRODUCTION

About Certara

Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. Our goal is to enable the life sciences industry’s use of data, modeling, and analytics to make better decisions across the various phases of discovery and drug development. Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI resulting in significant opportunities to decrease the cost and increase the probability of success for new drug approval and commercialization.

About the Role

The SEND Explorer team is seeking a highly skilled Product Team Member with deep expertise in the CDISC SEND (Standard for Exchange of Nonclinical Data) standard. In this role, you will be instrumental in shaping product capabilities that enable pharmaceutical, biotech, and research organizations to efficiently visualize, analyze, and derive insights from nonclinical study data in SEND datasets and beyond.

You will work closely with cross-functional partners including developers and customer-facing teams to define product requirements, validate solutions, and support customers in their adoption of SEND Explorer features, ensuring that they derive maximum value from the application.

This is an ideal opportunity for someone passionate about nonclinical data standards, data transformation, data visualization, and building products that unleash the full value of structured datasets, while also helping our customers embrace emerging AI technology and drivers to reduce animal usage in nonclinical safety assessment.

Responsibilities

Product Development & Strategy

- Serve as a subject matter expert (SME) on CDISC SEND standard structures, controlled terminology, implementation guides, and regulatory expectations.
- Translate customer needs and regulatory requirements into clear product requirements, user stories, acceptance criteria, and feature specifications.
- Collaborate with the product development team to ensure accurate implementation of functionality, including data ingestion, validation, visualization, and analysis workflows.
- Participate in product roadmap planning, feature prioritization, and release scoping.

Data & Standards Expertise

- Review, test, and validate product functionality using SEND datasets across study types and versions (e.g., SENDIG 3.x, SEND for carcinogenicity, immunotoxicology, etc.).
- Monitor CDISC updates, FDA expectations, and industry trends (including pending changes from SEND 4.0); assess impact on the product and recommend necessary enhancements.

Customer & Stakeholder Engagement

- Work directly with customers, partners, and internal teams to gather insights, troubleshoot issues, and understand usage patterns.
- Support customer onboarding and adoption by explaining SEND data structure, workflows, and product capabilities.
- Provide SEND-related visualization knowledge resources such as documentation, training materials, and internal enablement content.
- Provide demos and training to support customers.

Quality, Testing & Documentation

- Perform functional and user acceptance testing of new SEND Explorer features and ensure alignment with product design and data standards.
- Develop, review, and update product documentation, help content, and user guides related to SEND features and best practices.

QUALIFICATIONS

Required

- Bachelor's degree required in relevant field, Advanced degree in relevant field preferred (e.g. MS, MPH, MBA, etc.)
- Expert-level knowledge of the CDISC SEND standard, including datasets, variables, controlled terminology, domains, and implementation guide requirements.
- 7+ years of experience working with nonclinical study data, regulatory submissions, data standards, or related fields.
- Experience with tools used to create, validate, transform, or analyze SEND datasets.
- Strong analytical skills and comfort working with data-heavy product features.
- Ability to explain complex requirements in a clear and accessible manner.
- Independent, excellent communication, documentation, and cross-functional collaboration skills.

Preferred

- Experience in product management, product owner roles, or contributing to software product development.
- Familiarity with FDA regulatory submissions involving SEND datasets.
- Experience working with UX, engineering, or data architecture teams.
- Understanding of nonclinical study design, toxicology endpoints, and digital data workflows.
- Familiarity with SDLC, Agile methodologies, and tools such as Jira or Azure DevOps.

Core Competencies

- Customer Focus – Understands customer needs and translates them into actionable product requirements.
- Technical Curiosity – Able to dive deep into SEND datasets and product behavior.
- Problem-Solving – Breaks down complex data and workflow challenges.
- Communication – Articulates requirements clearly and effectively, both written and verbal.
- Adaptability – Thrives in a fast-paced, evolving environment.
- Independent Learning and Initiative – Proactively seeks out knowledge, self-educates on complex concepts, and drives work forward with minimal direction.

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.