Medical Writer II - Clinical & Regulatory Expert

Trident Consulting Inc; Aliso Viejo (CA); On-site; USD 58,000 - 61,000; Part time

Job summary

Trident Consulting Inc in Aliso Viejo, CA is seeking a Medical Writer II for a 6-month contract to produce high-quality clinical and regulatory documentation, translating complex data into clear reports.

The role collaborates with project teams across departments, ensures accuracy, adheres to regulatory guidelines, and maintains editorial standards. Ophthalmology experience with conference submissions is a plus.

Qualifications

• 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.
• Experience supporting clinical study reports, protocols, publications, abstracts, posters, or similar scientific documents is preferred.

Responsibilities

• Prepare clinical study reports (CSRs) under supervisor direction and translate data into a report of study outcomes.
• Translate clinical study synopses into full clinical study protocols with input from project teams.
• Interpret data and apply regulatory knowledge to document preparation.
• Review, edit, and ensure consistency and compliance across documents.
• Develop and maintain lists of abstract submission deadlines and key dates for ophthalmology conferences.
• Coordinate with Clinical and R&D teams to support conference abstract submissions and regulatory guidance.

Skills

Clinical research

Medical writing

Regulatory documentation

Editing & proofreading

Project management

Communication skills

Education

Bachelor's degree in Life Sciences or related

Tools

Microsoft Office Suite

Adobe Acrobat

Document management systems

Job description

Trident Consulting Inc in Aliso Viejo, CA is seeking a Medical Writer II for a 6-month contract to produce high-quality clinical and regulatory documentation, translating complex data into clear reports.

The role collaborates with project teams across departments, ensures accuracy, adheres to regulatory guidelines, and maintains editorial standards. Ophthalmology experience with conference submissions is a plus.