At Asthra AI , we’re leading the charge in AI-driven automation for regulatory documents, transforming the way the pharmaceutical industry drafts and submits clinical trial-related documents. We are looking for an experienced Lead, Clinical Regulatory Writing & AI Solutions to join our dynamic startup. If you have a strong background in drafting clinical trial documents such as protocols, CSRs, and Investigator Brochures (IB) etc., and are passionate about innovation in the regulatory space, this role is for you. Key Responsibilities: Clinical Document Drafting & Template Development: Create and refine templates for key clinical trial documents (e.g., Protocols, CSRs, IB etc.) aligned with industry standards. Prompt Engineering: Develop and enhance prompts for AI-driven document automation, ensuring they meet regulatory requirements and maintain high standards. Brand Development: Build and strengthen Asthra’s brand presence as a leader in clinical regulatory expertise. Industry Engagement: Represent Asthra AI at industry events, conduct product demos, and help position us as a trusted name in clinical regulatory writing. Ideal Candidate: Experience: 5-10 years in regulatory writing, specifically focused on clinical trial-related documents (e.g., Protocols, CSRs, IB, etc.). Skill Set: Proven expertise in clinical regulatory document drafting with a keen eye for detail. Open to learning and applying prompt engineering for AI solutions. Traits: Resourceful, proactive, and collaborative. A passion for working in a fast-paced, innovative environment. Passion: Deep interest in clinical regulatory writing and AI-driven innovation for the pharma industry. Why Join Us? Startup Environment: Work in a cutting-edge startup where innovation is at the core of everything we do. Cross-functional Collaboration: Collaborate with a talented team of AI experts, engineers, and regulatory professionals to bring groundbreaking solutions to life. If you're excited about advancing clinical regulatory writing through AI and want to be part of a groundbreaking team, we want to hear from you.
As a Lead, Clinical Regulatory Writing & AI Solutions at Asthra AI, you will play a pivotal role in revolutionizing the pharmaceutical industry by leveraging AI-driven automation for regulatory documents. Your expertise in drafting clinical trial-related documents such as protocols, CSRs, and Investigator Brochures (IB) will be instrumental in shaping the future of clinical regulatory writing. Your key responsibilities will include creating and refining templates for essential clinical trial documents, ensuring alignment with industry standards. You will also be responsible for developing and enhancing prompts for AI-driven document automation, guaranteeing compliance with regulatory requirements and maintaining high-quality standards. Additionally, you will play a vital role in building and strengthening Asthra's brand presence as a leader in clinical regulatory expertise. As the ideal candidate for this role, you should possess 5-10 years of experience in regulatory writing, with a specific focus on clinical trial-related documents. Your skill set should demonstrate proven expertise in clinical regulatory document drafting, with a keen eye for detail. You should be open to learning and applying prompt engineering for AI solutions. Additionally, you should exhibit traits such as resourcefulness, proactiveness, and collaboration, along with a deep passion for working in a fast-paced, innovative environment. Joining Asthra AI will offer you the opportunity to work in a cutting-edge startup environment where innovation is at the core of everything we do. You will collaborate with a talented team of AI experts, engineers, and regulatory professionals to bring groundbreaking solutions to life. If you are enthusiastic about advancing clinical regulatory writing through AI and aspire to be part of a pioneering team, we are excited to hear from you.,