Principal Medical Writer

ICON Strategic Solutions; United States; On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Principal Medical Writer to join their team. This role involves managing the medical writing function, creating and reviewing clinical documents, and contributing to oncology study protocols. The ideal candidate will have a strong background in medical writing, excellent communication skills, and the ability to interpret clinical data effectively. The company prioritizes a diverse culture that rewards high performance and offers competitive benefits focused on well-being and work-life balance. If you are passionate about making a difference in clinical research, this opportunity is for you.

Benefits

Various Annual Leave Entitlements

Health Insurance Offerings

Competitive Retirement Planning

Global Employee Assistance Programme

Life Assurance

Flexible Optional Benefits

Qualifications

• 5+ years of experience in medical writing in the pharmaceutical/CRO industry.
• Advanced degree preferred and excellent writing skills required.

Responsibilities

• Manages all aspects of the medical writing function.
• Writes and reviews clinical study reports and protocols.

Skills

Medical Writing

Excellent Writing Skills

Interpersonal Communication

Data Interpretation

Project Prioritization

Education

Advanced Degree in Scientific/Clinical/Regulatory Field

Tools

PleaseReview

Documentum-based Platforms

MS Word

MS Excel

MS PowerPoint

MS Outlook

Job description

Corporate Recruiter at ICON Strategic Solutions

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

What you will be doing:

• Manages all aspects of the medical writing function.
• Writes and reviews clinical study reports, protocols, and other clinical/regulatory documents.
• Contributes to clinical protocol development for first-in-human oncology studies.
• Demonstrates technical expertise and background in the use of medical writing templates and software (eg, PleaseReview, Documentum-based platforms, etc.).
• Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents.
• Drives the document preparation process, receives and reviews primary statistical output, drafts and distributes documents for review, and incorporates/resolve comments with all reviewers.
• Acts as a lead medical writer on complex programs and numerous individual studies.

You are:

• Advanced degree in a relevant scientific/clinical/regulatory field preferred.
• At least 5 years of experience in a lead medical writing role in the pharmaceutical/CRO industry. *Note: Immunology experience is preferred but not required.
• Excellent writing skills.
• Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
• Knowledge of current requirements and guidelines applicable to submission documents.
• Excellent interpersonal and oral communication skills.
• Strong knowledge of MS Word, Excel, PowerPoint, and Outlook.
• Ability to prioritize multiple projects.
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family.

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Research

Industries

Pharmaceutical Manufacturing