Senior Specialist, Global Clinical Evaluation – MedTech Surgery

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Drives ongoing improvements in Global Clinical Evaluation processes by focusing on enhancing, automating, and standardizing literature searches and reporting, while remaining updated on industry trends, notified body guidelines, and global regulatory agency best practices in training, education, and knowledge enablement.

• Designs and delivers training sessions for Global Clinical Evaluation and other departments as needed, covering Global Clinical Evaluation activities, outcomes, strategic initiatives, and quality objectives.

• Takes responsibility for the comprehensive planning and execution of all assigned Global Clinical Evaluation deliverables (e.g., protocols, reports, regulatory responses).

• Guarantees timely provision of high-quality services and documentation, ensuring consistent implementation throughout MedTech Surgery.

• Develops, executes, and maintains relevant procedures, templates, best practices, style standards, reference libraries, reviewer guidelines, and quality control measures.

• Oversees the application and integration of platforms and software that support systematic literature reviews, including statistical analysis tools.

• Identifies key stakeholders and establishes effective communication models.

• Coordinates both internal and external Medical Writing resources (writers, reviewers, project managers, medical information specialists, librarians, vendors) to achieve project objectives.

• Aids in the professional development of internal team members.

• Collaborates actively with Global Clinical Evaluation teams and cross-functional business partners, such as Medical Directors, Medical Safety, Post Market Surveillance, Clinical Affairs, Design Quality Engineers, R&D, and Regulatory Affairs regarding Global Clinical Evaluation deliverables and initiatives.

• Conducts technical reviews of data or reports intended for incorporation into Global Clinical Evaluation deliverables and/or regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.

• Partners with vendors and service providers to facilitate the introduction of scalable tools, automation, and AI-driven solutions where applicable.

• Monitors key performance indicators, tracks metrics, and communicates issues or areas for improvement to leadership.

• Ensures that relevant writing processes are linked to appropriate Quality Systems and Regulatory Processes (e.g., Risk Management, PMS, etc.), thus supporting data and information accessibility.

• Assists with managing the Global Clinical Evaluation budget, including performing resource updates and approving invoices.

⛳️ Requirements

• BA/BS degree required; advanced degree preferred.

• A minimum of 6 years of experience in EUMDR, clinical evaluation reports, systematic literature reviews, or a closely related regulatory/clinical field is required.

• Proven knowledge and experience in narrative or systematic literature reviews (e.g., PRISMA, Cochrane) with qualitative and quantitative synthesis alongside scientific and medical writing are required.

• Demonstrated knowledge and experience in clinical research methodologies, including common biostatistical methods, systematic reviews, clinical data appraisal, and medical writing are essential.

• Familiarity with global medical device regulations and guidelines is preferred.

• Expertise in change management is required.

• Knowledge of automation and artificial intelligence opportunities related to medical/technical writing is preferred.

• Experience with regulatory/Notified Body front room audits is preferred.

• Background in mentoring medical/technical writers, managing high-volume project work, and supervising internal and external writers/vendors is preferred.

🏝️ Benefits

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; for employees residing in Colorado – 48 hours per calendar year; for employees residing in Washington – 56 hours per calendar year.

• Holiday pay, including Floating Holidays – 13 days per calendar year.

• Work, Personal, and Family Time – up to 40 hours per calendar year.

• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.

• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.

• Caregiver Leave – 80 hours in a 52-week rolling period.

• Volunteer Leave – 32 hours per calendar year.

• Military Spouse Time-Off – 80 hours per calendar year.