Medical Writer

TriloDocs (part of Genactis Group); Birmingham; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A leading tech company in regulatory writing is seeking a Medical Writing Specialist to support internal teams and clients. This role focuses on regulatory writing, particularly Module 2.7 and 2.5 and Clinical Study Reports. The ideal candidate will have 2–5 years of experience and excellent communication skills. This position offers the opportunity to influence regulatory writing technology through innovative solutions in a hybrid working environment.

Benefits

Flexible working options

Growth opportunities

Collaborative culture

Qualifications

• 2–5 years of regulatory medical writing experience in biotech, pharma, or CRO.
• Hands-on experience with Module 2.7 and Module 2.5 writing.
• Strong ability to communicate complex regulatory concepts.

Responsibilities

• Serve as an internal SME on regulatory medical writing.
• Guide product teams in understanding regulatory writing workflows.
• Engage with clients on sales and onboarding.

Skills

Regulatory medical writing

Interpersonal and communication skills

Technical curiosity

Job description

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.