At a Glance
- Tasks: Lead AI-driven regulatory and medical writing projects for biotech and pharma clients.
- Company: Join IntuitionLabs, a pioneer in AI solutions for the biotech industry.
- Benefits: Enjoy a competitive salary, fully remote work, and flexible hours.
- Other info: Collaborate with industry experts and receive structured training on AI tools.
- Why this job: Transform the future of medical writing with cutting-edge AI tools.
- Qualifications: 5-10 years in regulatory or medical writing; PhD preferred.
The predicted salary is between 110000 - 135000 $ per year.
IntuitionLabs helps biotech and pharmaceutical companies put AI to work across regulatory, clinical, quality, medical and business teams. Our clients are biotech and pharmaceutical companies across North America. We run company-wide AI programs month by month: training, platform setup, and working tools built with each department.
This is a remote position with flexible hours. Candidates based in Canada or the United States are preferred. We are building a full-time delivery team of people from the industry who use AI every day. This role joins that team, reporting to our Head of Delivery.
What you will do
- Lead the regulatory and medical writing month of our programs at each client: map how the team produces its documents today, measure the time it takes, and build AI workflows the writers keep using.
- Show regulatory and medical writers how to draft, review and cross-check documents with Claude and ChatGPT, including agents that work across many documents at once.
- Build templates, prompt sets and source-traced drafting workflows for documents such as IND sections, protocols, investigator brochures, clinical study reports and briefing documents.
- Build and teach training material in our Academy: workshops, guides and short videos for scientists, writers and business teams.
- Answer client questions through our help desk and office hours, and keep the monthly scorecard current.
- Work alongside a network of senior specialists in regulatory, quality, clinical, medical and commercial functions.
What you bring
- 5 to 10 years in regulatory affairs, regulatory writing or medical writing, at a biotech, pharmaceutical company or CRO.
- A PhD in a life science is preferred (PharmD or MD also considered).
- Working knowledge of ICH guidelines and the CTD structure.
- Flawless written and spoken English.
- Daily use of AI tools in your own work, and clear views on where they fail.
- The ability to teach experienced professionals without talking down to them.
- Availability for some meetings on Eastern and Pacific time.
What we offer
- Fully remote, with flexible hours.
- Salary CAD 110,000 to 135,000.
- Structured training on Claude, ChatGPT and agentic tools from the first week.
- Direct work with the founder, the Head of Delivery and senior industry specialists.
- Work that changes how regulated documents get written.
AI Specialist, Regulatory and Medical Writing – Remote in Winnipeg employer: IntuitionLabs
IntuitionLabs is an exceptional employer that fosters a collaborative and innovative work culture, allowing you to work directly with industry leaders while managing impactful AI programs in the biotech and pharmaceutical sectors. With flexible hours and a fully remote setup, employees enjoy a healthy work-life balance and ample opportunities for professional growth and development in a cutting-edge field.
