
Harvest Integrated Research Organization (HiRO) is a global, boutique Clinical Research Organization (CRO) that streamlines and accelerates cross-border clinical trial pathways for pharmaceutical and…

Harvest Integrated Research Organization (HiRO) is a global, boutique Clinical Research Organization (CRO) that streamlines and accelerates cross-border clinical trial pathways for pharmaceutical and…
About the Role
We're looking for an experienced Medical Writer to join our team and play a key role in supporting the development of compounds across early and late-stage clinical programs. You'll work as part of a cross-functional team, contributing to the strategic design, execution, and interpretation of clinical studies and turning complex data into clear, high-quality documents that support regulatory submissions and publications.
This is a hands-on role where you'll be involved in everything from protocols and clinical study reports through to manuscripts, conference presentations, and due diligence assessments. If you enjoy variety, thrive in a fast-paced environment, and take pride in producing sharp, well-structured scientific writing this could be a great fit.
What You'll Be Doing
Working closely with internal teams and external partners, you'll be responsible for authoring and managing a broad range of clinical and regulatory documents, including but not limited to synopses, protocols, clinical development plans, investigator's brochures, informed consent forms, clinical study reports, and briefing books for FDA submission.
You'll also support the preparation and presentation of non-clinical, clinical, efficacy, and safety data for assigned projects, whether that's for internal portfolio reviews, scientific advisory groups, or external partners. Beyond regulatory documents, you'll contribute to publications including abstracts, manuscripts, and conference presentations.
Staying current with regulatory and compliance requirements across key markets is an important part of the role, and you'll be expected to ensure all documents align with the broader development strategy and target labelling objectives.
What We're Looking For
Why Join Us?
You'll be part of a growing team that values quality, accountability, and collaboration. This role offers genuine exposure to end-to-end drug development and the opportunity to make a meaningful contribution across a diverse portfolio of clinical programs.
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