Principal Scientist, Instructions Use; IFU Strategy Lead

Position: Principal Scientist, Instructions for Use (IFU) Strategy Lead
Location: Malvern

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Job Function:
R&D Product Development
Job Sub Function:
Industrial Design & Human Factors
Job Category:
Scientific/Technology
All Job Posting Locations:
Malvern, Pennsylvania, United States of America
Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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We are searching for the best talent for Principal Scientist, Instructions for Use (IFU) Strategy Lead located in Malvern, Pennsylvania.

Purpose: The IFU Strategy Lead will work within the Human Factors & User Experience team in the Drug Delivery Systems (DDS) group as part of the greater Drug Product Development & Delivery (DPD&D) organization.

This role presents the opportunity to create a new aligned strategy for IFU development within DDS that will support Johnson & Johnson Innovative Medicine's entire portfolio, including common combination products like prefilled syringes and autoinjectors, products using novel delivery systems, and drug-only products with unique preparation requirements. The IFU Strategy Lead will build on existing achievements from individual products, learn and understand legacy processes, capture lessons learned from development and post-market data, and formulate best practices to roll out as a consistent and coherent approach to creating IFUs.

Success will rely on a high degree of cross functional collaboration with key partners, including leaders in human factors, device, and primary container engineering, device education, artwork, labeling, clinical development, global and regional commercial organizations, supply chain, quality, and regulatory.

You will be responsible for:

• Lead the DDS strategy for the development of IFU documents for drug and combination products
• Coordinate IFU development for all active R&D programs from early phase trials through pivotal and into commercial launch
• Support implementation of quality document management system to track IFU materials during development
• Collaborate with quality, commercial, and supply chain partners on post-launch IFU updates
• Influence cross functional decision making to ensure IFU design choices and overall strategy are aligned with data-driven inputs and user-centered principles
• Support and innovate on data collection practices related to IFU user success, preference, and engagement
• Incorporate learnings from post-launch surveillance data into IFU strategy and active R&D programs

Qualifications / Requirements:

• Minimum of a bachelor's degree in engineering, behavioral science, regulatory science, clinical practice, or related field is required plus 6 years of relevant experience OR Master's, or doctoral or advanced clinical practice degrees are preferred with 3 + years of relevant experience

• Relevant experience must include combination product development, drug or medical device product labeling, human factors engineering, instructional design, or another relevant field
• Demonstrated capacity to influence and lead in group environments
• Ability to learn and adapt to changing timelines and portfolio priorities
• Desire to collaborate to improve ways of working
• Strong written and verbal communication skills

Preferred Education and Skills:

• Authorship or review of regulatory submissions of product labeling
• Involvement with studies of use behavior, preference, and engagement related to instructional materials
• Experience training patients, caregivers, or health care providers on the use of drug and combination products
• Familiarity with regulations governing IFU, labeling, and other materials associated with drug and combination products
• Knowledge of trends and approaches in current combination product IFUs across the industry, including digital innovation
• Use of quality document management systems

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Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion,…