Johnson and Johnson is recruiting for an Associate Director IPV Affairs Medical Device Lead, which can be located in one of our current Innovative Medicine hubs. This role will be working in a hybrid model. We can consider experienced individuals in another EMEA location than mentioned, but relocation cannot be covered.
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 where 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
Principal Responsibilities The IPV Affairs Medical Device (MD) Lead will support the IPV Team in all strategic realizations and compliance operations related to the vigilance of the MD J&J; IM portfolio under the umbrella of International Pharmacovigilance (IPV). In addition, they will ensure a consistent compliance and operations approach across the regions in alignment with the Global Medical Safety (GMS) processes with a specific focus on Medical Devices and Combination products in the J&J; IM portfolio.
You will become the subject matter expert for MD questions within the IPV organization and will support the assessment and implementation of MD legislation with regional/global impact in IPV and provide expertise to Local Medical Safety Teams on local MD requirements as needed.
In this position, you will work closely with internal and external partners in the MD area by leading or participating in global or regional multi-disciplinary projects and shaping strategies for the projects assigned.
Key Responsibilities: Represent and promote the culture and vision of the Office of the Chief Medical Officer, J&J; Innovative Medicine (IM OCMO)
Collaborate with various teams to ensure compliant Device processes across IPV
Liaise between Global/Regional IPV Leadership teams and GMS, advocating for IPV organization and developing strategies
Improve IPV-owned processes and influence efficiency and compliance across IPV - Take ownership of global MD IPV processes, working with SMEs
Lead Capability development for MD in IPV
Support audit readiness and inspections for MD-related activities
Assist in audits, inspections, and global CAPAs in IPV related to MD
Identify MD trends and opportunities for the IPV Leadership team
Collaborate on regulatory compliance for MD portfolio with Regional Heads and Local Safety Officers
Document compliance processes and translate MD requirements into regional/global IPV processes
Act as MD legislation SME for regional/global impact in IPV
Lead or participate in global/regional MD projects and shape strategies
Lead MD Core Team in IPV and shape MD QMS and processes
Collaborate with Global Medical Safety and other partners to influence IPV's MD strategy
Proactively identify compliance risks and coordinate investigations and action plans
Lead discussions on MD implementation in IPV
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