Ferris Mfg. Corp.
The Senior Medical Writer develops high-quality scientific, clinical, and regulatory documents to support the development, approval, and commercialization of injury and wound care medical products. This role combines scientific expertise with writing and project management skills to communicate complex clinical and technical information clearly and compliantly, serving as a key liaison across multiple teams.
Key Responsibilities
- • Author, co-Author, edit, and manage key clinical and regulatory documents, including regulatory submissions (e.g., 510(k), CE Mark documentation, MDR, etc)
- • Author risk–benefit analyses and safety narratives
- • Ensure documents align with applicable guidelines (ICH‑GCP, FDA, EMA, MDR)
- • Write clear, concise, and scientifically accurate materials such as manuscripts and journal articles, abstracts, presentations, posters for scientific conferences, white papers, technical summaries, medical education content, literature reviews, and gap analyses
- • Translate complex data into formats suitable for varied audiences (regulators, clinicians, internal teams)
- • Work closely with regulatory affairs and quality teams
- • Lead clinical insight review meetings and incorporate stakeholder feedback efficiently
- • Review and interpret clinical and scientific data to ensure accuracy and consistency across documents
- • Ensure documents reflect robust scientific messaging and strategic objectives
- • Perform quality checks for clarity, consistency, grammar, formatting, and compliance
- • Manage multiple writing projects simultaneously with minimal supervision
- • Develop timelines and ensure on‑time delivery across complex, matrixed teams
- • Maintain document version control and contribute to document templates, style guides, and SOPs
Required
- • Advanced degree required: PhD, PharmD, MD, DMS, DMSc, or MS in a scientific or health-related discipline
- • Strong knowledge of clinical research, medical terminology, and scientific methodologies
- • 5–10+ years of professional medical writing experience in medical devices, pharmaceuticals, or biotechnology
- • Proven experience writing clinical and regulatory documents
- • Experience working with cross-functional teams in a highly regulated environment
- • Exceptional written and verbal communication skills
- • Ability to synthesize complex data into clear, structured narratives
- • Strong understanding of FDA, MDR and ICH guidelines
- • Proficiency with literature databases and reference management tools (PubMed, EndNote, etc.)
- • Strong attention to detail, organization, and project management
Preferred
- • Scientific reasoning – ability to analyze and interpret clinical/technical data
- • Strategic mindset – ability to align messaging with clinical and business goals
- • Collaboration – success in matrixed, small business environments
- • Regulatory fluency – understanding of global submission requirements
- • Wound Care - understanding the science and clinical application of wound care and wound healing
About Ferris Mfg. Corp.
Ferris Mfg. Corp., a privately owned company founded in 1977, is the producer and distributor of PolyMem® dressings, an innovative class of multifunctional wound care products. PolyMem dressings uniquely combine cleansing, filling, absorbing, and moisturizing capabilities to support the entire wound-healing process without additional supplies or costs. With its headquarters in Fort Worth, Texas, Ferris is committed to designing and delivering superior-quality products that adhere to international standards and regulations. Learn more at www.polymem.com.
Role Summary
The Senior Medical Writer is responsible for developing high‑quality scientific, clinical, and regulatory documents that support the development, approval, and commercialization of injury and wound care medical products. This role combines deep scientific expertise with strong writing and project management skills to ensure clear, accurate, and compliant communication of complex clinical and technical information. The Senior Medical Writer serves as a key liaison across Clinical, Regulatory, Medical Affairs, and R&D teams.
Key Responsibilities
Clinical & Regulatory Document Development
- Author, co-Author, edit, and manage key clinical and regulatory documents, including:
- Regulatory submissions (e.g., 510(k), CE Mark documentation, MDR, etc
- Risk–benefit analyses and safety narratives
- Ensure documents align with applicable guidelines (ICH‑GCP, FDA, EMA, MDR).
Scientific & Medical Writing
- Write clear, concise, and scientifically accurate materials, such as:
- Manuscripts and journal articles
- Abstracts, presentations, and posters for scientific conferences
- White papers, technical summaries, and medical education content
- Literature reviews and gap analyses
- Translate complex data into formats suitable for varied audiences (regulators, clinicians, internal teams).
Cross-Functional Collaboration
- Work closely with, regulatory affairs and quality teams.
- Lead review clinical insight review meetings and incorporate stakeholder feedback efficiently.
Data Interpretation & Quality Assurance
- Review and interpret clinical and scientific data to ensure accuracy and consistency across documents.
- Ensure documents reflect robust scientific messaging and strategic objectives.
- Perform quality checks for clarity, consistency, grammar, formatting, and compliance.
Project Management
- Manage multiple writing projects simultaneously with minimal supervision.
- Develop timelines and ensure on‑time delivery across complex, matrixed teams.
- Maintain document version control and contribute to document templates, style guides, and SOPs.
Qualifications
Education
- Advanced degree required: PhD, PharmD, MD, DMS, DMSc, or MS in a scientific or health-related discipline.
- Strong knowledge of clinical research, medical terminology, and scientific methodologies.
Experience
- 5–10+ years of professional medical writing experience in medical devices, pharmaceuticals, or biotechnology.
- Proven experience writing clinical and regulatory documents.
- Experience working with cross-functional teams in a highly regulated environment.
Skills & Competencies
- Exceptional written and verbal communication skills.
- Ability to synthesize complex data into clear, structured narratives.
- Strong understanding of FDA, MDR and ICH guidelines
- Proficiency with literature databases and reference management tools (PubMed, EndNote, etc.).
- Strong attention to detail, organization, and project management.
Key Competency Areas
- Scientific reasoning – ability to analyze and interpret clinical/technical data.
- Strategic mindset – ability to align messaging with clinical and business goals.
- Collaboration – success in matrixed, small business environments.
- Regulatory fluency – understanding of global submission requirements.
- Wound Care-understanding the science and clinical application of wound care and wound healing
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