Principal Medical Writer

PRA International; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

PRA International is seeking a Principal Medical Writer to join their leading clinical research organization. The role involves preparing and reviewing clinical study documents, collaborating with various teams, and providing scientific expertise. Candidates should have an advanced degree and significant experience in medical writing within the pharmaceutical or biotechnology sectors. With a focus on mentorship and collaboration, this position offers opportunities for professional development and a supportive environment.

Benefits

Annual leave entitlements

Health insurance options

Retirement planning

Global Employee Assistance Programme

Life assurance

Childcare vouchers

Gym discounts

Travel passes

Health assessments

Qualifications

• 5-7 years of medical writing experience in pharma, biotech, or CRO industries.
• Knowledgeable of regulatory requirements (e.g., ICH-GCP, FDA, EMA).
• Strong interpersonal skills and ability to collaborate with diverse teams.

Responsibilities

• Lead preparation of clinical study documents including protocols and reports.
• Collaborate with cross-functional teams to interpret clinical data.
• Participate in planning and executing clinical development programs.

Skills

Writing

Editing

Communication

Interpreting clinical data

Project management

Education

Advanced degree in Life Sciences, Pharmacy, Medicine, or related field

Job description

Overview

As a Principal Medical Writer, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

Responsibilities

What you will be doing

• Leading the preparation, review, and editing of clinical study documents, including protocols, reports (CSRs), investigator brochures (IBs), and regulatory submissions, ensuring accuracy, clarity, and compliance with guidelines and standards.

• Collaborating with cross-functional teams such as clinical research, biostatistics, regulatory, and medical affairs to interpret clinical data, summarize findings, and communicate insights.

• Participating in planning and executing clinical development programs, providing scientific expertise to support study design, conduct, and interpretation.

• Contributing to publication plans, abstracts, posters, and manuscripts for peer-reviewed journals and conferences, disseminating study results.

• Mentoring junior medical writers, guiding on best practices, writing techniques, and fostering a culture of excellence and collaboration.

Qualifications

You Are:

• Having an advanced degree in Life Sciences, Pharmacy, Medicine, or related field, with 5-7 years of medical writing experience in pharma, biotech, or CRO industries.

• Proficient in interpreting complex clinical data, with excellent writing, editing, and communication skills for diverse audiences.

• Knowledgeable of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and experienced in interactions with regulatory agencies.

• Capable of managing multiple projects in a fast-paced, deadline-driven environment, prioritizing effectively.

• Possessing strong interpersonal skills, with the ability to collaborate and influence stakeholders.

What ICON can offer you: We prioritize building a diverse culture that rewards high performance and nurtures talent. Our benefits include:

• Annual leave entitlements
• Health insurance options
• Retirement planning
• Global Employee Assistance Programme
• Life assurance
• Optional benefits like childcare vouchers, gym discounts, travel passes, health assessments, and more.

Learn more about working at ICON: https://careers.iconplc.com/benefits

We are committed to inclusion & belonging, providing an accessible environment free of discrimination. If you need accommodations during the application process, please let us know through this form.

We encourage you to apply even if you’re unsure about meeting all requirements – you might be exactly what we’re looking for.