Principal Medical Writer

Summary

Join Natera as a Principal Medical Writer, Clinical Affairs and lead the development and execution of clinical and performance study documentation for in vitro diagnostic (IVD) products. You will author key regulatory documents like CPSPs, IBs, and PSRs, collaborating with cross-functional teams and external partners. This role requires expertise in clinical study design, evidence generation, and regulatory compliance, particularly under the IVDR. You will contribute to clinical strategy, oversee documentation submission, and ensure compliance with evolving regulations. The position offers a competitive salary and a comprehensive benefits package. Natera is a global leader in cell-free DNA testing, committed to a diverse and inclusive workplace.

Requirements

• Bachelor’s degree in a scientific or medical discipline is required
• 8–12+ years of experience in medical writing or a closely related field within the diagnostics, pharmaceutical, or medical device industry, with a demonstrated track record of producing high-quality clinical and regulatory documentation
• Hands-on experience developing Clinical Performance Study Plans (CPSPs), Investigator’s Brochures (IBs), Performance Study Reports (PSRs), and other documentation in support of regulatory submissions under IVDR or similar frameworks
• Proven ability to manage multiple priorities and complex projects in a fast-paced, cross-functional environment, while maintaining attention to detail and regulatory compliance
• Strong communication and collaboration skills, with the ability to interface with cross-functional teams, including Regulatory Affairs, Clinical Affairs, Medical Affairs, and Scientific Communications

Responsibilities

• Lead the creation and review of Clinical Performance Study Plans (CPSPs), Investigator’s Brochures (IBs), and Performance Study Reports (PSRs) in accordance with global regulatory requirements (e.g., IVDR, FDA, ISO 20916)
• Support clinical strategy and study design, providing clinical input on study plan/protocol development, and planning for performance studies involving in vitro diagnostics (IVDs), including companion diagnostics (CDx)
• Act as the Clinical Affairs representative on cross-functional teams, including Medical Affairs, Regulatory Affairs, Scientific Communications, Product Development, and Business Development—offering subject matter expertise on clinical evidence generation and regulatory compliance across global geographies
• Coordinate or contribute to the development of submission-ready documentation, including clinical study summaries, and clinical-based responses to regulatory authorities for CE marking or other global approvals
• Collaborate with external partners including contractors, vendors, pharmaceutical sponsors, academic and consortia groups to ensure alignment on study-related deliverables
• Contribute to continuous improvement of clinical affairs processes, including SOP development, templates, and workflows to support documentation quality, operational efficiency, and regulatory readiness
• Serve as the clinical affairs representative in cross-functional teams, including Medical Affairs, Regulatory Affairs, Scientific Communications, Product Development, and Business Development, providing expertise on clinical study design and regulatory compliance under the IVDR
• Oversee the preparation and submission of clinical study documentation for regulatory purposes
• Stay informed of evolving regulations and standards, ensuring clinical processes remain compliant and efficient

Preferred Qualifications

• Professional certifications (e.g., RAC, ACRP, CCRP, or equivalent)
• In-depth knowledge of IVDR and performance study documentation requirements, particularly for companion diagnostics (CDx)
• Background in oncology, molecular diagnostics, or related clinical fields is strongly preferred
• Experience in medical writing for medical devices and/or in vitro diagnostics is highly valued, especially in the context of European and global regulatory pathways

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Natera employees and their immediate families receive free testing in addition to fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• Generous employee referral program