Clinical Medical Writer II - Ophthalmology & Regulatory

Trident Consulting Inc; Aliso Viejo (CA); Sur place; USD 58 000 - 61 000; Plein temps

Résumé du poste

Trident Consulting Inc. is seeking a Medical Writer II for a 6-month assignment in the United States. The role focuses on high-quality clinical and regulatory documentation, translating complex data into clear narratives, and ensuring compliance with regulatory guidelines and templates.

Collaboration with cross-functional teams, preparation of CSRs and study-related documents, and careful attention to detail are essential. The position offers standard W2 pay of $42-44/hr for first shift work.

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 preferred.
• Familiarity with publication development and scientific communication processes preferred.
• Ophthalmology experience preferred.
• 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.

Responsabilités

• Prepare clinical study reports (CSRs) under supervisor direction. Based on the clinical study protocol and statistical analysis plan, translate clinical results data tables, listings, and figures into a report of study outcomes, complete final checks for data consistency, and ensure compliance with applicable regulatory requirements.
• Translate clinical study synopses into full clinical study protocols, ensuring appropriate depth, technical accuracy, and consistency. Collaborate with project team members to gather required input and feedback.
• Interpret data, analyze results, and apply knowledge of scientific, regulatory, and compliance requirements to document preparation.
• Systematically review reports and clinical data and cross-check information for completeness and accuracy.
• Ensure consistency in style, tone, and quality across all assigned documents.
• Conduct medical and scientific literature searches to support clinical and regulatory documentation.
• Review, edit, and cross-check documents produced by team members for clarity, accuracy, consistency, and compliance.
• Stay current with industry trends, regulatory requirements, and best practices in medical writing and clinical research.
• Develop and maintain lists of abstract submission deadlines, and key dates for major ophthalmology and related scientific conferences.
• Coordinate with Clinical, and R&D teams to support conference abstract submissions while ensuring compliance with conference guidelines and company objectives.
• Prepare, edit, and proof presentations, slide decks, posters, and other scientific communications for internal and external stakeholders.
• Assist in the development of figures, tables, and graphical content for publications, presentations, and posters.
• Manage multiple writing assignments simultaneously and prioritize deliverables to support project timelines.
• Participate in project team meetings and provide updates regarding documentation status and deliverables.

Connaissances

Medical writing

Regulatory knowledge

Data interpretation

Editing

Communication

Cross-functional collaboration

Ophthalmology experience

Formation

Bachelor's degree in Life Sciences

Advanced degree preferred

Outils

Microsoft Office

Adobe Acrobat

Document management systems

Description du poste

Trident Consulting Inc. is seeking a Medical Writer II for a 6-month assignment in the United States. The role focuses on high-quality clinical and regulatory documentation, translating complex data into clear narratives, and ensuring compliance with regulatory guidelines and templates.

Collaboration with cross-functional teams, preparation of CSRs and study-related documents, and careful attention to detail are essential. The position offers standard W2 pay of $42-44/hr for first shift work.