AI Solutions Strategist – Medical Writing

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!

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