Sr. Medical Writer at Glaukos Corporation
Glaukos Corporation · Aliso Viejo, United States Of America · Onsite
- Professional
- Office in Aliso Viejo
This role will be responsible for producing high-quality clinical and clinical regulatory documentation that will require a strong understanding of medical and regulatory concepts and terminology as well as the ability to translate complex information into clear and concise documentation. Will work closely and collaborate with project teams spanning multiple departments on Glaukos's current and pipeline of products. The Sr. Medical Writer will be responsible for engaging with cross-functional stakeholders to extract key information, and synthesize that into a clear, logical presentation. You will ensure that documentation is accurate, complete, meets editorial and client specifications, and adheres to established guidelines and standards.
Responsibilities
- Prepares clinical study reports (CSRs) with limited supervisor direction – based on the clinical study protocol and statistical analysis plan, translates clinical result data tables, listings and figures into a report on the study outcomes, completes final check for discrepancies within data, and ensures compliance with relevant regulatory agencies.
Translate clinical study synopsis into full clinical study protocol, ensuring appropriate level of depth and detail, as well as technical accuracy. Works with other members of the project team to obtain input.
Interpret data, analyze results, and apply knowledge of regulatory/compliance/scientific requirements to document preparation.
Systematically review reports and clinical data and cross-check information
Ensure consistency in style, tone, and quality across all documents.
Develop and maintain standardized templates and style guides for clinical and regulatory documentation.
Conduct medical and scientific literature database research to support documentation efforts.
Review, edit, and cross-check documents produced by other team members for clarity, accuracy, and compliance.
Stay up-to-date with industry trends, regulatory requirements, and best practices in both technical and medical writing.
Develop and maintain lists of abstract deadlines, key dates, and locations for relevant/major ophthalmology conferences. Coordinate with R&D leadership to prepare conference abstract submissions while ensuring compliance with conference rules and company objectives and strategy.
Prepare and proof presentations (slide decks and posters) as required for physicians and other key internal stakeholders
Develop figures for publications and presentations (peer-reviewed publications, presentations, and posters) to align with company strategy
Support phase I through phase IV studies prior to database lock, identifying any adverse events or protocol deviations and works with cross-functional
Participate in project meetings and provide updates on the status of writing assignments.
Qualifications
- Bachelor's Degree Required
- Master's Degree or
- PhD Preferred
- 5-8 years of relevant work experience in a clinical or scientific space
- Deep understanding of therapeutic areas, clinical research, and regulatory requirements
- Fluency in technical and medical terminology
- Experience in pharmaceutical regulatory submissions
- Experience with scientific publications and presentations
- Familiarity with ophthalmic indications and treatments preferred
- Excellent writing, editing, and proofreading skills
- Proficiency in using documentation tools and software such as Microsoft Office Suite, Adobe Acrobat, and content management systems (CMS)
- Strong organizational and project management skills
- Excellent communication and interpersonal skills
