Senior Specialist, Global Clinical Evaluation - MedTech Surgery
Johnson & Johnson
4 days ago
Remote
United States
Clinical Research and Development
Senior Specialist, Global Clinical Evaluation
You will be responsible for (under limited supervision of the Director, Global Clinical Evaluation):
- Drive continuous process improvement for global clinical evaluation (improve/automate/standardize literature searching and reporting; stay current with regulatory trends; support training/knowledge enablement).
- Create and deliver training across Global Clinical Evaluation and other departments.
- Own end-to-end planning and execution of assigned deliverables (protocols, reports, regulatory responses).
- Ensure timely, high-quality services and consistent documentation deployment across MedTech Surgery.
- Develop/maintain procedures, templates, style standards, reference libraries, reviewer guidelines, and quality control tools.
- Manage integration of platforms/software for systematic literature reviews (incl. statistical analysis tools).
- Coordinate medical writing resources (writers, reviewers, PM, librarians, vendors) to meet project goals; support professional development.
- Partner cross-functionally (Medical Directors, Medical Safety, Post Market Surveillance, Clinical Affairs, Design Quality Engineers, R&D, Regulatory Affairs).
- Provide technical review for scientific rigor/accuracy/clarity; support scalable tool/automation/AI solutions.
- Track KPIs/metrics; ensure writing processes link to Quality/Regulatory processes (e.g., Risk Management, PMS).
- Assist with budget management (resourcing updates; invoice approvals).
Qualifications / Requirements:
- BA/BS required; advanced degree preferred.
- 6+ years’ experience in EUMDR, clinical evaluation reports, systematic literature reviews, or related regulatory/clinical field.
- Experience with narrative/systematic reviews (PRISMA, Cochrane) with qualitative/quantitative synthesis and medical/scientific writing.
- Clinical research methodologies with biostatistics, systematic reviews, clinical data appraisal, and medical writing.
- Change management expertise required.
Preferred:
- Global medical device regulations/guidelines; automation/AI opportunities; regulatory/Notified Body “front room” audit; mentoring/managing high-volume projects and internal/external writers/vendors.
Required/Preferred Skills:
- Analytical reasoning; Clinical Operations; Clinical Research & Regulations; Communication; Developing others; Ethical & participant safety considerations; Good Clinical Practice (GCP); Inclusive leadership; Leadership; Operational excellence; Process oriented; Team management.
Benefits (time off): Vacation (120 hrs/year); Sick time (40 hrs/year, CO 48, WA 56); Holiday pay incl. floating holidays (13 days/year); Work/Personal/Family time (up to 40 hrs/year); Parental leave (480 hrs); Bereavement (240 hrs immediate family; 40 hrs extended); Caregiver leave (80 hrs in 52-week rolling period); Volunteer leave (32 hrs/year); Military spouse time-off (80 hrs/year).
You will be responsible for (under limited supervision of the Director, Global Clinical Evaluation):
- Drive continuous process improvement for global clinical evaluation (improve/automate/standardize literature searching and reporting; stay current with regulatory trends; support training/knowledge enablement).
- Create and deliver training across Global Clinical Evaluation and other departments.
- Own end-to-end planning and execution of assigned deliverables (protocols, reports, regulatory responses).
- Ensure timely, high-quality services and consistent documentation deployment across MedTech Surgery.
- Develop/maintain procedures, templates, style standards, reference libraries, reviewer guidelines, and quality control tools.
- Manage integration of platforms/software for systematic literature reviews (incl. statistical analysis tools).
- Coordinate medical writing resources (writers, reviewers, PM, librarians, vendors) to meet project goals; support professional development.
- Partner cross-functionally (Medical Directors, Medical Safety, Post Market Surveillance, Clinical Affairs, Design Quality Engineers, R&D, Regulatory Affairs).
- Provide technical review for scientific rigor/accuracy/clarity; support scalable tool/automation/AI solutions.
- Track KPIs/metrics; ensure writing processes link to Quality/Regulatory processes (e.g., Risk Management, PMS).
- Assist with budget management (resourcing updates; invoice approvals).
Qualifications / Requirements:
- BA/BS required; advanced degree preferred.
- 6+ years’ experience in EUMDR, clinical evaluation reports, systematic literature reviews, or related regulatory/clinical field.
- Experience with narrative/systematic reviews (PRISMA, Cochrane) with qualitative/quantitative synthesis and medical/scientific writing.
- Clinical research methodologies with biostatistics, systematic reviews, clinical data appraisal, and medical writing.
- Change management expertise required.
Preferred:
- Global medical device regulations/guidelines; automation/AI opportunities; regulatory/Notified Body “front room” audit; mentoring/managing high-volume projects and internal/external writers/vendors.
Required/Preferred Skills:
- Analytical reasoning; Clinical Operations; Clinical Research & Regulations; Communication; Developing others; Ethical & participant safety considerations; Good Clinical Practice (GCP); Inclusive leadership; Leadership; Operational excellence; Process oriented; Team management.
Benefits (time off): Vacation (120 hrs/year); Sick time (40 hrs/year, CO 48, WA 56); Holiday pay incl. floating holidays (13 days/year); Work/Personal/Family time (up to 40 hrs/year); Parental leave (480 hrs); Bereavement (240 hrs immediate family; 40 hrs extended); Caregiver leave (80 hrs in 52-week rolling period); Volunteer leave (32 hrs/year); Military spouse time-off (80 hrs/year).