Client Solutions Architect

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 creativity 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 Solutions Architect with a specialization in medical writing of regulatory documents to join our AI team. The successful candidate will be responsible for designing and implementing generative AI workflows for regulatory submission documents via Certara's CoAuthor technology. They will work closely with clients to understand their business needs and develop customized demos and generative AI strategies for implementation of CoAuthor document automation. The Client Solutions Architect will also work with our development team to ensure that solutions are delivered on time and within budget.

• Develop, test and deploy generative AI prompts for various use cases, including for the generation of regulatory documents
• Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents using generative AI
• Be proactive in creating and optimizing regulatory writing workflows that are compatible with emerging AI technology, regulatory writing best practices, and ICH guidelines
• Support sales and product teams in customer support and strategic consulting of generative AI deployment within regulatory writing teams
• Develop generative AI prompts to client specifications, templates, style guides and other guidance documents
• Author documents per regulatory authority guidelines and requirements
• Act as client advisor, working collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result
• Maintain collaborative, proactive, and effective communication with both client and internal teams
• Ability to run product and generative AI demos
• Run internal organization and external customer prompt engineering trainings

Qualifications

• Master's degree in the Life Sciences (MSc/MSci/MRes) required, PhD or MD will be advantageous
• 2 + years of regulatory writing experience required.
• Broad experience across the CTD (clinical, nonclinical, safety, CMC, patient-facing documents), or experience authoring larger documents (Module 2.5 or Module 2.7), will be advantageous.
• Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance
• Experience in the development of submission-level documents (does not require functioning as a document lead)
• A demonstrated interest in linguistics, GenAI prompt patterns, and programming will be beneficial

Skills & Abilities:

• Proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques
• Strong understanding of the document creation process and of the drug development lifecycle
• Ability to teach new users how to use generative AI efficiently and effectively
• Able to optimize templates by rapidly clarifying instructional text
• Able to synthesize data across multiple data sources and documents to create summary reports
• Expertise in the use of generative AI and basic prompt engineering best practices
• Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making
• Develops professional relationships with clients as a way to further the business relationship and maintain current industry knowledge
• Ability to identify, test and establish new generative AI use cases within regulatory writing
• Ability to resolve problems that arise, particularly in sensitive or high-pressure situations
• Possesses broad experience and technical expertise across more than one therapy area

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.