Client Implementation and Medical Writing Consultant

Overview

Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and proactivity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies. 

We are looking for a Client Implementation Consultant with a background in medical writing to join our existing CoAuthor team. CoAuthor is Certara's AI-enabled regulatory writing solution, built to help writing teams draft and review high-quality, submission-ready documents faster. The successful candidate will learn CoAuthor in depth, understand the challenges faced by writers, reviewers, and the wider authoring workflow, and use that knowledge to train, educate, and empower our clients to get the most from the tool. This role is focused on enablement and does not carry account management responsibility. The Client Implementation Consultant will also work with our product and development teams to bring the voice of the writer into the product.

Responsibilities

• Develop deep expertise in CoAuthor's features, templates, and AI capabilities, and stay up-to-date as the product evolves
• Plan and deliver onboarding, training, and ongoing enablement for client writers, reviewers, and project teams through live sessions, workshops, and office hours
• Understand each client's regulatory writing workflow, including drafting, review, QC, and approval, and recommend how CoAuthor fits into it
• Configure CoAuthor for clients, including setting up templates and prompts that reflect their document types and standards
• Guide clients in using AI-assisted writing responsibly, including effective prompting, verifying AI output, and keeping a human in the loop
• Create training materials, quick-start guides, and best-practice resources for clients and internal teams
• Identify adoption challenges and workflow friction early, and partner with account and product teams to address them
• Capture client feedback and share it with Product and Development as clear, actionable input
• Participate in client meetings, product demonstrations, and technical evaluations, bringing medical writing credibility to conversations with current and prospective clients
• Collaborate with the existing team to share knowledge and continually improve our enablement approach
• Manage multiple client engagements simultaneously and ensure that timelines are met

Qualifications

• Bachelor's degree in life sciences or a related field; advanced degree (MS, PhD, PharmD) preferred
• At least 3 years of regulatory or medical writing experience in pharma, biotech, or a CRO, authoring documents such as clinical study reports, protocols, investigator brochures, or CTD modules
• Strong understanding of the regulatory writing workflow and the challenges faced by writers and reviewers
• Demonstrated interest in, and willingness to learn, AI-enabled tools; hands-on experience with generative AI is a plus
• Comfortable learning and configuring new software, with strong working knowledge of Microsoft Word
• Experience training, mentoring, or presenting to groups, with excellent communication and interpersonal skills
• Strong problem-solving skills, with the ability to diagnose workflow issues and turn them into practical solutions
• Ability to work independently and as part of a team
• Strong organizational skills and the ability to manage multiple projects at once
• Preferred: experience in software training, implementation, or customer enablement, and familiarity with regulated (GxP) environments

If you are a medical writer who is excited about AI, enjoys helping others succeed with new tools, and is looking for an opportunity to work with a dynamic team, we would love to hear from you.

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.