Lead Medical Writer, Phase I-IV (Global)

Worldwide Clinical Trials; Milwaukee (WI); On-site; USD 67,000 - 132,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Late Phase Medical Writer II to carry out medical writing activities for Phase I–IV studies across USA, Europe, and ROW, ensuring regulatory compliance and high-quality output within budgets. The role requires leading writing teams and collaborating with sponsors to deliver study documents on time.

Responsibilities include preparing ICFs, CTRs, Investigator Brochures, and region-specific submissions, and coordinating review cycles.

Qualifications

• Requires a university/college degree in life sciences or related field.
• Minimum 3 years of medical writing experience or equivalent.
• Willingness to travel domestically and internationally.

Responsibilities

• Lead the medical writing team on Phase I–IV study documents in accordance with sponsor specifications and regulatory requirements.
• Prepare and lead documents such as protocols, informed consent documents, CTRs, and Investigator Brochures; include region-specific documents outside the USA.
• Coordinate internal and sponsor document review cycles; ensure quality and timely delivery.
• Review and perform MW QC reviews of documents as needed.

Skills

Excellent English

Data interpretation

Project/time management

Independent work

MS Word

PowerPoint

Excel

Outlook

Communication across teams

Education

Life science degree

Job description

Worldwide Clinical Trials is seeking a Late Phase Medical Writer II to carry out medical writing activities for Phase I–IV studies across USA, Europe, and ROW, ensuring regulatory compliance and high-quality output within budgets. The role requires leading writing teams and collaborating with sponsors to deliver study documents on time.

Responsibilities include preparing ICFs, CTRs, Investigator Brochures, and region-specific submissions, and coordinating review cycles.