What are the responsibilities and job description for the AI Solutions Strategist – Medical Writing position at Unicon Pharma Inc?
🚀 Hiring: AI Solutions Strategist – Medical Writing
Are you a seasoned Medical Writing professional with expertise in Regulatory Affairs and a passion for AI-driven innovation?
We're looking for an experienced professional with 10–15 years of regulatory and clinical medical writing experience to help transform the future of medical writing through AI-enabled solutions.
What You'll Do:
- Lead the development of high-quality regulatory and clinical documents (INDs, NDAs, BLAs, CTDs, CSRs, Protocols, IBs, and more).
- Ensure consistency and scientific accuracy across the product evidence narrative.
- Drive the adoption and governance of AI-enabled medical writing platforms.
- Collaborate with cross-functional teams and senior stakeholders to deliver submission-ready documents.
- Shape the future of AI-assisted medical writing in a regulated pharmaceutical environment.
What We're Looking For:
- 10–15 years of medical writing experience in Pharma, Biotech, or CRO.
- Strong knowledge of FDA, EMA, ICH, and global regulatory submissions.
- Experience with clinical and regulatory documentation.
- Exposure to Generative AI or AI-assisted medical writing workflows is highly preferred.
- Excellent communication, leadership, and stakeholder management skills.
If you're passionate about combining science, regulatory strategy, and AI to transform healthcare, we'd love to connect!