Senior Specialist, Global Clinical Evaluation - MedTech Surgery
Johnson & Johnson
August 08, 2026
Remote
United States
Clinical Research and Development
Senior Specialist, Global Clinical Evaluation
You will be responsible for:
- Drive continuous process improvement for Global Clinical Evaluation (improve/automate/standardize literature searching and reporting; stay current on regulatory/NB trends; training and knowledge enablement).
- Create and deliver training on Global Clinical Evaluation activities, results, and strategic/quality initiatives.
- Own end-to-end planning and execution of Global Clinical Evaluation deliverables (e.g., protocols, reports, regulatory responses).
- Ensure timely delivery of high-quality services/documentation and consistent deployment across MedTech Surgery.
- Develop and maintain procedures, templates, reference libraries, reviewer guidelines, quality control tools/measures.
- Manage platforms/software for systematic literature reviews (including statistical analysis tools) and integrate utilization.
- Identify stakeholders and implement effective communication models.
- Coordinate internal/external medical writing resources; support professional development of internal resources.
- Partner cross-functionally (Medical Directors, Medical Safety, Post Market Surveillance, Clinical Affairs, Design Quality Engineers, R&D, Regulatory Affairs).
- Perform technical review to ensure scientific rigor/accuracy/clarity; support scalable tools/automation/AI with vendors.
- Track KPIs/metrics, report issues/opportunities; link writing processes to Quality/Regulatory Systems.
- Assist with Global Clinical Evaluation budget (resourcing updates, invoice approvals).
Qualifications / Requirements:
- BA/BS required; advanced degree preferred.
- 6+ years in EUMDR, clinical evaluation reports, systematic literature reviews, or related regulatory/clinical field.
- Experience in narrative/systematic literature reviews (e.g., PRISMA, Cochrane) with qualitative/quantitative synthesis and scientific/medical writing.
- Experience in clinical research methodologies (biostatistics, systematic reviews, clinical data appraisal) and medical writing.
- Preferred: global medical device regulations/guidelines; regulatory/Notified Body “front room” audit experience; change management; automation/AI opportunities; mentoring/supervising high-volume writers/vendors.
- Remote position; 20% domestic/international travel.
Benefits (time off; subject to policy): Vacation 120 hrs/yr; sick time 40 hrs/yr (state-based variants); holiday pay 13 days/yr; parental leave 480 hrs/yr; bereavement leave; caregiver leave; volunteer leave; military spouse time-off.
You will be responsible for:
- Drive continuous process improvement for Global Clinical Evaluation (improve/automate/standardize literature searching and reporting; stay current on regulatory/NB trends; training and knowledge enablement).
- Create and deliver training on Global Clinical Evaluation activities, results, and strategic/quality initiatives.
- Own end-to-end planning and execution of Global Clinical Evaluation deliverables (e.g., protocols, reports, regulatory responses).
- Ensure timely delivery of high-quality services/documentation and consistent deployment across MedTech Surgery.
- Develop and maintain procedures, templates, reference libraries, reviewer guidelines, quality control tools/measures.
- Manage platforms/software for systematic literature reviews (including statistical analysis tools) and integrate utilization.
- Identify stakeholders and implement effective communication models.
- Coordinate internal/external medical writing resources; support professional development of internal resources.
- Partner cross-functionally (Medical Directors, Medical Safety, Post Market Surveillance, Clinical Affairs, Design Quality Engineers, R&D, Regulatory Affairs).
- Perform technical review to ensure scientific rigor/accuracy/clarity; support scalable tools/automation/AI with vendors.
- Track KPIs/metrics, report issues/opportunities; link writing processes to Quality/Regulatory Systems.
- Assist with Global Clinical Evaluation budget (resourcing updates, invoice approvals).
Qualifications / Requirements:
- BA/BS required; advanced degree preferred.
- 6+ years in EUMDR, clinical evaluation reports, systematic literature reviews, or related regulatory/clinical field.
- Experience in narrative/systematic literature reviews (e.g., PRISMA, Cochrane) with qualitative/quantitative synthesis and scientific/medical writing.
- Experience in clinical research methodologies (biostatistics, systematic reviews, clinical data appraisal) and medical writing.
- Preferred: global medical device regulations/guidelines; regulatory/Notified Body “front room” audit experience; change management; automation/AI opportunities; mentoring/supervising high-volume writers/vendors.
- Remote position; 20% domestic/international travel.
Benefits (time off; subject to policy): Vacation 120 hrs/yr; sick time 40 hrs/yr (state-based variants); holiday pay 13 days/yr; parental leave 480 hrs/yr; bereavement leave; caregiver leave; volunteer leave; military spouse time-off.