Principal Medical Writer

Pharmaceutical Research Associates, Inc; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

Join a leading clinical research organization as a Principal Medical Writer, where you will manage the medical writing function and contribute to developing clinical protocols for oncology studies. This role involves writing and reviewing critical documents such as clinical study reports and protocols, ensuring clarity and compliance with regulatory guidelines. You will leverage your extensive experience and excellent writing skills in a dynamic environment, collaborating with various stakeholders to present complex data effectively. This is a fantastic opportunity to make a significant impact in the field of clinical research and contribute to groundbreaking studies.

Qualifications

• 5+ years of experience in a lead medical writing role in the pharmaceutical/CRO industry.
• Knowledge of current requirements for submission documents.

Responsibilities

• Manage all aspects of the medical writing function and write clinical documents.
• Drive the document preparation process and act as lead medical writer.

Skills

Excellent writing skills

Ability to understand and interpret clinical data

Interpersonal and oral communication skills

Ability to prioritize multiple projects

Education

Advanced degree in a relevant scientific/clinical/regulatory field

Tools

PleaseReview

Documentum-based platforms

MS Word

Excel

PowerPoint

Outlook

Job description

Overview

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

Responsibilities

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 (e.g., 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/resolves comments with all reviewers.
• Acts as a lead medical writer on complex programs and numerous individual studies.

Qualifications

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.