Advance Clinical Science as a Medical Writer II in Shanghai
Shape the Future of Clinical Development with a Global Leader
ICON plc is a world-leading healthcare intelligence and clinical research organization. We are dedicated to fostering an inclusive and innovative environment that drives excellence in clinical development. We invite you to join our mission to bring new treatments to patients worldwide.
We are seeking a skilled Medical Writer II to join our dynamic team in Shanghai. In this role, you will be instrumental in developing high-quality clinical and regulatory documents that support the advancement of innovative therapies and ensure regulatory compliance across global markets.
What You Will Be Doing
Regulatory & Clinical Document Development
- Collaborate with cross-functional teams to write, edit, and finalize key documents, including Clinical Study Reports (CSRs), Clinical Protocols, Investigator Brochures (IBs), patient narratives, and other regulatory submissions.
- Ensure all documents comply with ICON standards, ICH-GCP guidelines, and regional regulatory requirements (including NMPA standards).
Scientific Communication & Publication
- Conduct literature reviews and analyze clinical trial data to support the development of scientific manuscripts, abstracts, posters, and conference presentations for peer-reviewed journals and scientific meetings.
- Interpret and communicate complex clinical results clearly and accurately for diverse audiences.
Data Review & Quality Assurance
- Assist in the review and validation of clinical data, ensuring alignment with study protocols, SOPs, and regulatory expectations.
- Maintain meticulous attention to detail, consistency, and accuracy across all document types.
Stakeholder Collaboration
- Participate in project meetings, teleconferences, and client interactions to discuss objectives, timelines, and deliverables.
- Provide expert input on document structure, content, and presentation to meet both scientific and regulatory standards.
Continuous Learning
- Stay current with emerging trends, regulatory updates, and scientific advancements in relevant therapeutic areas.
- Apply evolving medical writing best practices to enhance the quality and impact of clinical documentation.
Your Profile
Essential Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field.
- Minimum of 3 years of medical writing experience within the pharmaceutical, biotechnology, or CRO industry.
- Proficiency in scientific and medical terminology, with excellent English written and verbal communication skills.
- Strong ability to interpret clinical data, identify key findings, and communicate results clearly and concisely.
- Familiarity with regulatory guidelines (ICH, NMPA, FDA, EMA) governing clinical documentation and submissions.
- Proficiency in Microsoft Office Suite; experience with document management systems, reference software (e.g., EndNote), and basic statistical tools is advantageous.
Ideal Candidate:
- Detail-oriented, analytical, and capable of managing multiple projects in a fast-paced environment.
- A collaborative team player with strong interpersonal skills and a client-focused approach.
- Committed to continuous improvement and professional development in medical writing.
What ICON Offers You
Our people are the foundation of our success. We are committed to supporting your well-being and professional growth with a comprehensive rewards package.
Benefits Include:
- Competitive salary and performance-based incentives.
- Generous annual leave entitlements.
- Comprehensive health insurance plans for you and your family.
- Retirement planning support to secure your future.
- Global Employee Assistance Programme (LifeWorks) – 24/7 access to well-being support.
- Life assurance coverage.
- Flexible local benefits, which may include childcare support, travel subsidies, wellness programs, and more.
Inclusion & Belonging:
At ICON, inclusion is fundamental to our culture. We provide an accessible, discrimination-free workplace and encourage applications from all qualified candidates. If you require accommodations during the application process, please let us know.
Interested but unsure if you meet every requirement? We encourage you to apply. You might be exactly who we're looking for—for this role or another within ICON.
Ready to contribute to groundbreaking clinical research from Shanghai?
Apply now to join ICON as a Medical Writer II.
ICON is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
