Medical Writer II

Trident Consulting • Aliso Viejo, CA

2d • Onsite

About The Position

This role will be responsible for producing high-quality clinical and clinical regulatory documentation that requires a strong understanding of medical and regulatory concepts and terminology, as well as the ability to translate complex information into clear and concise documentation. The Medical Writer II will work closely and collaborate with project teams spanning multiple departments on current and pipeline products. The Medical Writer II will be responsible for determining the clearest and most logical way to present clinical and scientific information. The individual will ensure that documentation is accurate, complete, meets editorial and quality standards, and adheres to established regulatory guidelines, templates, and company procedures.

Requirements

• 2-5 years of relevant experience in clinical research, medical writing, life sciences, biotechnology, pharmaceutical, or medical device industries.
• Strong understanding of clinical research methodologies, medical terminology, and scientific principles.
• Working knowledge of regulatory requirements and guidance applicable to clinical and regulatory documentation.
• Excellent writing, editing, proofreading, and organizational skills.
• Strong attention to detail and ability to evaluate complex scientific information.
• Proficiency with Microsoft Office Suite, Adobe Acrobat, and document management systems.
• Strong project management, communication, and interpersonal skills.
• Ability to work independently while collaborating effectively within cross-functional teams.

Nice To Haves

• Experience supporting clinical study reports, protocols, publications, abstracts, posters, or similar scientific documents.
• Familiarity with publication development and scientific communication processes.
• Ophthalmology experience.

Responsibilities

• Producing high-quality clinical and clinical regulatory documentation.
• Translating complex information into clear and concise documentation.
• Collaborating with project teams spanning multiple departments on current and pipeline products.
• Determining the clearest and most logical way to present clinical and scientific information.
• Ensuring documentation is accurate, complete, meets editorial and quality standards, and adheres to established regulatory guidelines, templates, and company procedures.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level