Sr. Medical Writer

Responsibilities

• Develop and refine clinical evaluation deliverables, including Clinical Evaluation Plans, Clinical Evaluation Reports, SSCPs, regulatory responses, and related documentation.
• Review and synthesize evidence from clinical studies, published literature, post-market surveillance, risk documentation, and post-market clinical evaluations.
• Support product applications and submissions by analyzing clinical data and preparing clear, accurate written materials.
• Collaborate with cross-functional partners across regulatory affairs, quality, clinical affairs, engineering, risk management, medical affairs, sales, marketing, and other stakeholder groups.
• Maintain familiarity with assigned products and incorporate relevant information from a wide range of technical and clinical sources.
• Review IFUs, patient materials, training content, risk files, protocols, plans, and reports to help ensure consistency and alignment.
• Contribute to responses to complex questions from external stakeholders and regulatory bodies.
• Ensure documentation quality, accuracy, consistency, and compliance with applicable policies, procedures, regulations, and guidance.

Requirements

• Bachelor’s degree or an equivalent combination of education and work experience.
• 6–8 years of medical writing experience in the medical or pharmaceutical industry, or 8+ years of general technical writing experience.
• Experience writing in a medical, pharmaceutical, medical device, clinical research, or related environment.
• Strong written and verbal communication skills with the ability to explain complex information clearly.
• Excellent analytical skills and the ability to manage multiple priorities and deadlines effectively.
• Comfort working in collaborative, cross-functional team settings.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
• Ability to produce accurate work with strong attention to detail and consistency.

Skills

• Bachelor’s degree or equivalent combination of education and work experience.
• 6–8 years of medical writing experience in the medical or pharmaceutical industry, or 8+ years of general technical writing experience.
• Experience writing in a medical, pharmaceutical, medical device, clinical research, or related environment.
• Strong written and verbal communication skills with the ability to explain complex information clearly.
• Excellent analytical skills and the ability to manage multiple priorities and deadlines effectively.
• Comfort working in collaborative, cross-functional team settings.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
• Ability to produce accurate work with strong attention to detail and consistency.

Preferred Skills

• Background in biomedical science, medicine, or another health-related discipline.
• Prior experience creating Clinical Evaluation Reports and related regulatory documents.
• Familiarity with clinical study design, clinical study management, quality engineering, or risk management.
• Experience working with medical device regulatory requirements and guidance, including ISO 13485, ISO 14155, ISO 14791, MEDDEV 2.7.1, MDR, and FDA/EU guidance.
• Ability to support responses to regulatory inquiries and external questions with sound judgment and professionalism.