Associate Director, Medical Writing & Literature Services – MedTech Surgery

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Function:
Data Analytics & Computational Sciences. Sub Function:
Clinical Data Management. Category:
People Leader. Locations:
Cincinnati, Ohio, United States of America;
Raritan, New Jersey, United States of America;
Remote (US).

Associate Director, Medical Writing & Literature Services – Remote work options may be considered on a case‑by‑case basis and if approved by the Company. The role acts as the central process owner for general medical writing activities and systematic literature reviews across J&J Med Tech Surgery, supporting Clinical, Medical, and Regulatory needs for all therapeutic areas within the J&J Med Tech Surgery business unit.

• Directs the planning and execution of systematic literature reviews (inclusive of protocol, search, screen, data extraction, analysis, and full summary report) for all applicable deliverables and processes, ensuring timely delivery of high-quality literature services and documentation as well as consistent deployment across Med Tech Surgery.
• Develops, implements, and maintains relevant procedures and templates, best practice and style standards, reference libraries, reviewer guidelines, and quality control tools/measures.
• Manages the utilization of software to support systematic literature reviews, including statistical analysis tools.
• Ensures the medical writing processes are linked to appropriate Quality Systems and Regulatory Processes (e.g., Risk Management, PMS, etc.), supporting data/information accessibility.
• Manages Medical Writing staff (i.e., medical writers and reviewers, project management staff, librarians, medical information specialists, programmers, as applicable to organizational structure).
• Provides strategic oversight and guidance for Medical Writing staff and cross‑functional business partners, if applicable, to all resources on compliant literature service execution and document generation.
• Establishes and maintains resource allocation / forecasting and operational direction for direct reports to achieve high-quality deliverables in an efficient manner.
• Maintains responsibility for talent acquisition and comprehensive training.
• Supports the professional development of direct reports.
• Leads literature process optimization with focus on improving efficiency, automating, and standardizing literature searching and reporting, staying current with industry trends and regulations.
• Partners with Global Clinical Evaluation teams and cross‑functional business partners such as Medical Affairs, Medical Safety, Post Market Surveillance, Clinical Affairs, Design Quality Engineers, R&D, and Regulatory Affairs relating to literature search and systematic review processes.
• Acts as the Global Clinical Evaluation literature services SME / liaison with respective Notified Bodies and regulatory agencies during audits and inspections.
• Tracks key performance indicators, maintains/monitors metrics, and reports issues or opportunities for improvement to Global Clinical Evaluation leadership.
• Supports the J&J Med Tech literature subscription process, enabling and maintaining appropriate access to the journals for cross‑functional teams.
• Assists in the development and management of the Global Clinical Evaluation budget including performing budget updates, ensuring appropriate assignment of resources, and approving invoices.
• Identifies and collaborates with vendors/service providers to source contract services necessary to accomplish literature services goals and objectives.

• Minimum of a Bachelor’s Degree required;
  Advanced Degree strongly preferred.
• Minimum 7 years of related medical writing experience including…