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 MedTech, 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. Learn more at https://www.jnj.com

Job Function:

Product Safety

Job Sub Function:

Product Safety Risk Management MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Horsham, 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.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Director, Medical Safety in Horsham, PA.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

Purpose: The Director, Medical Safety is responsible for working with the Chief Medical Officer (CMO) Consumer Health Products to advance strategic medical safety initiatives.  The Director will provide scientific expertise and work collaboratively with the CMO, others across the Office of the Chief Medical Officer, cross-functional partners and external stakeholders to help plan, design, manage and execute safety-related initiatives and projects.   

You will be responsible for:

• Working with the CMO to provide medical safety oversight for the benefit of patients
• Assisting with/supporting case processing, case reporting and the evaluation of safety data which, where applicable, may involve working with consultants and/or vendors and exerting appropriate oversight
• Assisting with/supporting the conduct of company-sponsored and/or investigator-initiated clinical studies which, where applicable, may involve working with consultants and/or vendors and exerting appropriate oversight
• Providing support for Health Authority inquiries and interactions regarding safety and risk management
• Helping to ensure quality and compliance and supporting related activities including potential audits and/or inspections
• Providing expertise, leadership, and advice to internal and external stakeholders on relevant safety topics.

Qualifications / Requirements:

• Education: Minimum of a Bachelor’s Degree is required.

Skills/Experience:

Required:

• Minimum of 10 years  of experience working within the pharmaceutical industry or related medical/scientific discipline(s)
• Experience working in medical safety/pharmacovigilance.  In depth understanding of safety regulations, including as they apply to Consumer Health products. 
• Experience assisting with/supporting case processing, case reporting and the evaluation of safety data.  Track record of developing effective risk mitigation strategies and/or leading safety-focused interventions which benefit patients, healthcare providers and/or health systems.

• Experience working in regulatory and/or experience directly interacting with health authorities.  Track record of developing effective strategies for and/or leading successful Health Authority engagements, inspections and/or outcomes.
• Experience working in clinical research and/or strong understanding of procedures and processes related to preclinical and/or clinical research.  Track record of supporting clinical research and/or working with cross-functional partners to develop effective pre-clinical or clinical strategies which are compliant, ethical and drive results.    
• Experience successfully working with consultants and/or vendors and exerting appropriate oversight. Track record of delivering high quality results through use of consultant and/or vendors.
• Experience working with external organizations (e.g. trade associations, professional organizations, consumer advocacy groups).  Track record of impact which benefits patients, public health and/or healthcare systems.
• Limited domestic (2-4 times per year) and international (1-2 times per year) travel
• Excellent English verbal and written communication skills

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. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

 

 

Required Skills:

 

 

Preferred Skills:

Clinical Operations, Compliance Management, Consulting, Design Mindset, Developing Others, Leadership, Medicines and Device Development and Regulation, Operational Excellence, Quality Control (QC), Research Ethics, Risk Compliance, Risk Management, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Succession Planning, Surveillance