Principal Medical Writer - Lead Clinical Docs & Submissions

ICON; United States; Remote; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Life insurance

Employee assistance program

Annual leave

Flexible benefits

Job summary

ICON, the world’s largest & most comprehensive clinical research organisation, is seeking a Principal Medical Writer to join our team. You will lead the creation and editing of protocols, CSRs, IBs, and submissions, ensuring clarity and regulatory compliance.

Collaborate with clinical research, biostatistics, regulatory affairs, and medical affairs; plan development programs; contribute to publications; mentor junior writers; support a culture of excellence.

Qualifications

• Advanced degree in Life Sciences, Pharmacy, Medicine, or related field, with 5–7 years of medical writing experience.
• Ability to interpret and summarize complex clinical trial data and scientific findings.
• Strong regulatory knowledge (ICH-GCP, FDA, EMA) and experience interacting with regulatory agencies.
• Experience leading publication planning, abstracts, posters, and manuscripts.
• Ability to mentor junior medical writers and foster learning within a team.

Responsibilities

• Lead the preparation, review, and editing of study documents (protocols, CSRs, IBs, regulatory submissions).
• Collaborate with cross-functional teams to interpret trial data and communicate insights in writing.
• Plan and execute clinical development programs, providing strategic scientific input.
• Contribute to development of publication plans, abstracts, posters, and manuscripts.
• Mentor and coach junior medical writers, promoting best practices and continuous learning.

Skills

Excellent writing and editing

Cross-functional collaboration

Interpreting complex clinical data

Mentoring junior writers

Regulatory knowledge (ICH-GCP, FDA,EMA

Deadline-driven multitasking

Education

Advanced degree in Life Sciences or related field

Job description

ICON, the world’s largest & most comprehensive clinical research organisation, is seeking a Principal Medical Writer to join our team. You will lead the creation and editing of protocols, CSRs, IBs, and submissions, ensuring clarity and regulatory compliance.

Collaborate with clinical research, biostatistics, regulatory affairs, and medical affairs; plan development programs; contribute to publications; mentor junior writers; support a culture of excellence.