Senior Level Senior Medical Writer Jobs

Job Summary
We are seeking a highly motivated and detail-oriented Medical Writer to join our dynamic team. In this role, you will be responsible for developing clear, accurate, and comprehensive scientific and medical documentation that supports clinical research, regulatory submissions, and medical communications. Your expertise will help bridge the gap between complex scientific data and accessible information, ensuring compliance with industry standards and regulations. This position offers an exciting opportunity to contribute to innovative healthcare solutions and advance your career in medical communications.

Responsibilities

• Develop and write a variety of scientific documents including clinical study protocols, investigator brochures, clinical study reports, regulatory submissions, and publication manuscripts.
• Collaborate with cross-functional teams such as clinical research, regulatory affairs, biostatistics, and medical affairs to gather necessary data and ensure consistency across documents.
• Ensure all written materials adhere to relevant guidelines including FDA regulations, ICH GCP (International Conference on Harmonisation Good Clinical Practice), JCAHO standards, and other applicable industry standards.
• Conduct thorough literature reviews and data analysis to support scientific claims and ensure accuracy in documentation.
• Maintain meticulous records of research findings, project timelines, and document revisions to facilitate seamless project management.
• Translate complex clinical research data into clear, concise language suitable for diverse audiences including regulatory bodies, healthcare professionals, and internal stakeholders.
• Assist in the review of clinical trial documentation for compliance with industry standards and provide technical writing expertise to enhance document quality.

Requirements

• Proven 10 years experience in clinical research or medical writing within biotechnology or healthcare settings; hospital experience is highly desirable.
• Strong knowledge of FDA regulations, ICH GCP guidelines, JCAHO standards, and Level I/II trauma center protocols.
• Demonstrated ability to analyze data accurately and synthesize findings into well-organized reports.
• Excellent technical writing skills with a keen eye for detail; ability to communicate complex concepts clearly.
• Familiarity with data collection tools, research methodologies, and clinical development processes.
• Valid certification in GCP (Good Clinical Practice), with an ICH GCP certificate from a recognized issuer for CA (California) preferred.
• Knowledge of managed care systems and healthcare policies is a plus.
• Strong project management skills with the ability to handle multiple projects simultaneously while meeting deadlines.
• Proficiency in medical terminology and scientific language; experience with data analysis software is advantageous. Join us if you’re passionate about advancing medical science through precise communication! This paid position offers an engaging environment where your expertise directly impacts healthcare innovation while supporting your professional growth in the field of clinical development and medical writing.

Pay: $150,000.00 - $200,000.00 per year

Benefits:

• 401(k)

Work Location: In person