Senior Staff Medical Writer

This is a fully remote position, open to applicants in California.

📋 Description

• Lead the creation and implementation of clinical evidence strategies for new product development and lifecycle management initiatives.

• Oversee clinical evaluation projects, ensuring alignment among clinical evidence, regulatory strategies, product claims, and commercialization goals.

• Write and maintain clinical evaluations, post-market clinical follow-up documentation, regulatory submissions, annual reports, and other clinical records.

• Design and conduct systematic literature reviews.

• Assess published evidence and integrate clinical, preclinical, and post-market data into scientifically substantiated conclusions.

• Evaluate the benefit-risk profiles of medical devices and formulate evidence-based recommendations in compliance with global regulatory standards.

• Collaborate with regulatory authorities and internal stakeholders to meet clinical evidence requirements and facilitate regulatory submissions.

• Create scientific communications, including manuscripts, conference abstracts, presentations, white papers, and materials for customers that present evidence.

• Mentor team members, guide cross-functional review processes, and identify areas for enhancing clinical evaluation methodologies, documentation practices, and team productivity.

⛳️ Requirements

• Master of Science degree in health, clinical, biological science, biomedical engineering, or a related scientific discipline.

• At least 6 years of experience in clinical affairs, regulatory affairs, quality assurance, medical writing, clinical evaluation, post-market surveillance, or a related field.

• A minimum of 2 years of experience in authoring clinical evaluations for medical devices.

• Proficient in conducting literature reviews, evidence synthesis, and scientific analysis utilizing clinical and/or technical data.

• Experience in supporting regulatory submissions and product lifecycle activities within a regulated healthcare environment.

• Preferred: Doctoral degree (PhD, PharmD, MD, or equivalent) in a health or science-related field.

• Preferred: Experience in meeting global medical device regulatory requirements, including clinical evaluation, post-market clinical follow-up, and market access activities.

• Preferred: Familiarity with global regulatory standards, including ISO, FDA, and international regulations.

• Preferred: Experience in managing complex cross-functional projects within the medical device sector.

🏝️ Benefits

• Remote position available within the United States.

• Travel requirement: None.

• Commitment to equal opportunity employment.

• Pay transparency and protections for compensation discussions.