Medical Writer II

About the role

ICON Strategic Solutions is looking for a Medical Writer II in Shanghai to join its sponsor-dedicated team. You will help develop and prepare clinical trial documents, regulatory submissions and scientific publications, supporting innovative treatments and therapies.

Key responsibilities

• Collaborate with cross-functional teams to prepare, write and edit clinical study reports (CSRs), clinical protocols, investigator brochures (IBs), patient narratives and other regulatory documents in line with internal standards and regulatory guidelines.
• Carry out literature reviews, analyse data and interpret clinical trial results to support scientific manuscripts, abstracts, posters and presentations for peer-reviewed journals and conferences.
• Help review and validate clinical data for accuracy, completeness and consistency with study protocols, SOPs and regulatory requirements.
• Take part in project meetings, teleconferences and client interactions, giving feedback on document content, format and presentation.
• Stay up to date with trends, scientific developments and regulatory updates in relevant therapeutic areas.

Required profile

• Bachelor's degree in Life Sciences, Pharmacy, Medicine or a related field.
• At least 3 years of experience in medical writing within pharma, biotechnology or a CRO.
• Proficiency in scientific and medical terminology, with strong written and verbal communication skills and attention to detail.
• Familiarity with regulatory requirements, industry guidelines and publication standards for clinical trial documents and manuscripts.
• Legal right to work in the country where the role is based.

Required skills

• Microsoft Office Suite (Word, Excel, PowerPoint)
• Document management systems, reference management software and statistical analysis tools are preferred

What we offer

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes, including medical, dental and vision coverage where applicable
• Retirement and pension plans, life assurance and disability coverage
• Employee assistance programmes and learning and development opportunities