Senior Staff Medical Writer

As the Senior Staff Medical Writer, you will lead the development of clinical evidence strategies and scientific documentation that support regulatory submissions, market access initiatives, and product lifecycle decisions. This position partners closely with Regulatory Affairs, Research and Development, Clinical, Marketing, and Quality teams to ensure clinical evidence is effectively evaluated, communicated, and applied throughout the product lifecycle.

What You Will Do

Lead the development and execution of clinical evidence strategies for new product development and lifecycle management activities.
Manage clinical evaluation projects, ensuring alignment between clinical evidence, regulatory strategy, product claims, and commercialization objectives.
Author and maintain clinical evaluations, post-market clinical follow-up documentation, regulatory submissions, annual reports, and other clinical documentation.
Design and execute systematic literature reviews, evaluate published evidence, and synthesize clinical, preclinical, and post-market data into scientifically supported conclusions.
Assess benefit-risk profiles of medical devices and develop evidence-based recommendations in accordance with global regulatory requirements.
Partner with regulatory authorities and internal stakeholders to address clinical evidence requirements and support regulatory submissions.
Develop scientific communications, including manuscripts, conference abstracts, presentations, white papers, and customer-facing evidence materials.
Mentor team members, lead cross-functional review processes, and identify opportunities to improve clinical evaluation methodologies, documentation practices, and team efficiency.

What You Need

Required

Master of Science degree in a health, clinical, biological science, biomedical, engineering, or related scientific field.
Minimum 6 years of experience in clinical affairs, regulatory affairs, quality, medical writing, clinical evaluation, post-market surveillance, or related field.
Minimum 2 years of experience authoring clinical evaluations for medical devices.
Experience conducting literature reviews, evidence synthesis, and scientific analysis using clinical and/or technical data.
Experience supporting regulatory submissions and product lifecycle activities within a regulated healthcare industry.

Preferred

Doctoral degree (PhD, PharmD, MD, or equivalent) in a health or science-related discipline.
Experience supporting global medical device regulatory requirements, including clinical evaluation, post-market clinical follow up, and market access activities.
Experience applying global regulatory requirements, including ISO, FDA, and international regulations
Experience managing complex cross-functional projects within the medical device industry.

United States of America Pay Ranges:

USN: $110,100 - $183,400 USD Annual
US5: $115,600 - $192,600 USD Annual
US10: $121,100 - $201,700 USD Annual
US15: $126,600 - $210,900 USD Annual
US20: $132,100 - $220,100 USD Annual
US30: $143,100 - $238,400 USD Annual