Role overview
IAG is seeking a
Medical / Technical Writer
with strong experience in clinical trial imaging, medical physics, biomedical engineering or similar to develop and maintain study‑level imaging documentation and scientific content across multiple biotech sponsors and therapeutic areas.
The role focuses on Independent Review Charters, Imaging Manuals, Reader materials and protocol‑driven analyses, and product specifications. You will be working closely with IAG’s scientific, operations and data teams.
Key responsibilities
- Draft and review imaging charters (eligibility, efficacy and safety sections) for multi‑centre imaging clinical trials across oncology, neurology, rheumatology and other indications.
- Develop imaging manuals (modalities such as MRI, CT, X‑ray, DXA, ultrasound, PET) with detailed acquisition parameters, timing, file naming and data transfer instructions for sites and vendors. This involves collaboration with IAG radiology teams.
- Prepare reader manuals (eligibility and efficacy) including scoring criteria, atlases, case examples and decision trees to support blinded independent central review (BICR).
- Create concise quick‑reference guides for specific modalities (e.g. DXA Lunar/Hologic, X‑ray checklists, rulers/phantoms) to support site compliance.
- Support protocol and protocol‑amendment imaging sections (endpoints, schedules, eligibility, concomitant medications) and provide written protocol analysis / impact assessments as needed.
- Author or contribute to quality documents such as Quality Monitoring Plans, CAPA responses, data handling / derivation plans for imaging endpoints, and internal SOP‑aligned templates.
- Develop reader training slide decks and session materials; document training attendance, knowledge‑check questions and training summaries.
- Provide ad‑hoc scientific consulting in writing (e.g. memos on implementation of specific criteria such as RANO 2.0, corticotherapy effects, new imaging biomarkers), including meeting preparation notes and follow‑up summaries.
- Perform medical / SME QC of imaging reports and study documents to ensure consistency with protocols, charters, regulatory guidance and IAG standards.
- Collaborate with project management, science and data teams to estimate effort, refine scopes and maintain document histories.
Required qualifications
- Advanced degree in medical physics, biomedical engineering, sciences, computer science or related field (PhD, MD, PharmD or MSc preferred).
- 3+ years of medical writing experience in clinical research, preferably with a CRO, imaging core lab, or pharma/biotech sponsor.
- Demonstrated experience drafting or revising clinical trial documents.
- Solid understanding of clinical trial design, ICH‑GCP and endpoint definition; familiarity with imaging‑based response criteria (e.g. RECIST, RANO) is highly desirable.
- Excellent written English, with the ability to translate complex scientific concepts into clear, practical guidance for sites and readers.
- Strong attention to detail, version control discipline and the ability to manage multiple deadlines across parallel studies.
Desired experience and skills
- Experience with multi‑modality imaging (MRI, CT, X‑ray, DXA, PET, ultrasound) in trials, including acquisition and central review workflows.
- Prior work on reader manuals or training for BICR, or on imaging‑related quality/monitoring plans.
- Comfort collaborating in a fully digital environment (Teams/Zoom, SharePoint, eTMF/DocuSign, task trackers, etc.).
- Ability to interact confidently with KOLs, radiologists and sponsor teams during document review cycles and scientific discussions.
Reporting line and location
- Reports to: Head of Scientific & Medical Affairs (Imaging) or designated Scientific Lead.
- Job location - flexible. IAG HQ are in London, UK, Philadelphia, USA and Hyderabad, India (where you will either work or visit).
About Image Analysis Group (IAG)
Image Analysis Group (IAG) is a science‑driven imaging CRO specializing in advanced imaging strategies and quantitative biomarkers for clinical trials. The company partners with biotech, pharmaceutical, and medical device organizations to design and deliver imaging‑enabled studies across oncology, neuro‑oncology, rheumatology, radio pharma, immunology, and metabolic diseases, providing robust data to support faster, more informed R&D decisions. For nearly 20 years, IAG has supported more than 700 clinical trials globally, helping biotech and pharmaceutical sponsors make confident, data‑driven decisions on their development portfolios.
Please send your CV and a short cover note (including writing examples) to
cv@ia-grp.com
Subject: Medical Writer
