Medical Writer
1 week ago
Medical Writer
Location:
United Kingdom (Remote/Hybrid)
Company:
TriloDocs
About TriloDocs
TriloDocs is a fast-growing tech company transforming how clinical and regulatory documents are created. We combine scientific expertise with powerful automation tools to help biotech and pharma organizations accelerate high-quality submissions. As we expand, we're looking for a Medical Writing Specialist who is excited about both regulatory science and modern technology.
Role Overview
We are seeking a UK-based Medical Writing Specialist with
2–5 years of hands-on regulatory medical writing experience
, particularly with
Module 2.7 (Clinical Overview)
and
Module 2.5 (Clinical Summary)
and/or
Clinical Study Reports (CSRs)
.
Unlike traditional writing roles, this position focuses on acting as a
Subject Matter Expert (SME)
to support our internal technical and product teams. You'll help us understand regulatory writing workflows, interpret industry best practices, and ensure our technology aligns with how medical writers actually think and work.
You will also engage directly with clients on early sales, onboarding, and support calls—helping translate medical writing needs into product solutions and building strong, trust-based relationships.
Key Responsibilities
- Serve as an
internal SME
on regulatory medical writing, including CSRs and Module 2 summaries. - Guide product and technical teams in understanding regulatory writing workflows, pain points, and real-world user needs.
- Participate in
client-facing calls
, including early sales conversations and support/onboarding sessions. - Translate medical writing requirements into actionable insights for our tech and product teams.
- Contribute to the development of templates, workflows, user training, and product improvements.
- Stay current with ICH, EMA, FDA and other relevant regulatory guidelines.
Required Qualifications
- 2–5 years of regulatory medical writing experience
(biotech, pharma, or CRO). - Hands on writing experience of
Module 2.7, Module 2.5, and/or CSR and
full-cycle understanding of delivery
structure and requirements
. - Based in the
United Kingdom
and eligible to work there. - Strong technical curiosity—comfortable learning new tools and collaborating with engineers and product managers.
- Excellent interpersonal and communication skills; enjoys engaging with clients.
- Ability to explain complex regulatory concepts clearly and succinctly.
Nice-to-Have
- Experience working with or supporting technology teams.
- Exposure to document automation or regulatory writing platforms.
- Startup or fast-paced environment experience.
Why Join TriloDocs?
- Help shape the next generation of regulatory writing technology.
- Use your medical writing expertise in a new, forward-looking way—less writing, more strategic influence.
- Work in a collaborative, innovative culture with significant growth opportunities.
- Flexible, UK-based remote/hybrid working options.
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