Johnson & Johnson MedTech is hiring: Associate Director, Medical Writing & Liter
Johnson & Johnson MedTech, Raritan, NJ, United States, 08869
Associate Director, Medical Writing & Literature Services – MedTech Surgery
Base pay: $137,000 – $235,750 per year.
Johnson & Johnson is a leader in healthcare innovation, dedicated to preventing, treating, and curing complex diseases. Through cutting‑edge medical technology and personalized solutions, we are building a healthier world that delivers breakthrough care for humanity.
Responsibilities
- Direct the planning and execution of systematic literature reviews, ensuring high‑quality deliverables across all therapeutic areas within MedTech Surgery.
- Develop and maintain procedures, templates, style standards, reference libraries, reviewer guidelines, and quality control tools.
- Manage software tools for statistical analysis and systematic literature reviews.
- Link medical writing processes to appropriate Quality Systems and Regulatory Processes, supporting data accessibility.
- Lead and mentor a diverse team of medical writers, reviewers, project managers, librarians, medical information specialists, programmers, and vendors.
- Provide strategic oversight and guidance to internal stakeholders to ensure compliant literature service execution and document generation.
- Establish and maintain resource allocation, forecasting, and operational direction for direct reports.
- Own talent acquisition and comprehensive training, supporting professional development of direct reports.
- Lead process optimization, improving efficiency, automating, and standardizing literature searching and reporting.
- Partner with Global Clinical Evaluation teams and cross‑functional partners such as Medical Affairs, Medical Safety, Post Market Surveillance, Clinical Affairs, Design Quality Engineers, R&D, and Regulatory Affairs.
- Act as the Global Clinical Evaluation literature services SME and liaison with regulatory agencies during audits and inspections.
- Track key performance indicators, monitor metrics, and report opportunities for improvement to Global Clinical Evaluation leadership.
- Support the J&J MedTech literature subscription process and vendor relationships.
- Assist in managing the Global Clinical Evaluation budget and invoice approval.
Qualifications
- Bachelor’s Degree required; Advanced Degree strongly preferred.
- Minimum 7 years of medical writing experience with at least 3 years of people leadership.
- Experience mentoring medical writers, managing high‑volume projects, and supervising internal and external writers/vendors.
- Experience within the medical device industry and clinical evaluation report regulatory requirements; global medical device regulations and guidelines knowledge required.
- Demonstrated experience in narrative or systematic literature reviews (PRISMA, Cochrane) with qualitative and quantitative synthesis.
- Knowledge of clinical research methodologies, biostatistics, systematic reviews, and medical writing.
- Project management, change management, budgeting, and financial planning skills.
- Remote work options may be considered on a case‑by‑case basis.
- 20% domestic and international travel required.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.