Medical Writer 2

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. 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.

Job Title: Medical Writer II 
Location: Aliso Viejo, CA 92656
Duration: 6+ Months


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 Clients 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.

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We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

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