Clinical Writer

Trident Consulting is seeking a "Clinical Writer” for one of our client in "Irvine, CA". A global leader in business and technology services.

Role: Clinical Writer

Location: Irvine, CA (contract-onsite)

Duration: 6 Months

Pay: $42- $44/hr on W2 (Inclusive all)

Shift: 1st Shift

Description

POSITION OVERVIEW: (An Overview of the Department & Summary of the Role)

• 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 Client' 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.

Responsibilities:

(Essential Functions and Associated Tasks for the Role)

• 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.
• Requirements

Work experience:

(Provide Experience, Knowledge, Skills & Abilities Required for the Role)

• 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.

Education:

• Bachelor's degree in Life Sciences, Biology, Chemistry, Biomedical Engineering, Pharmacy, Public Health, or a related scientific discipline required. Advanced degree (MS, PharmD, OD, PhD, MPH, or equivalent) preferred.