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.nj.om/ 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 JJ; 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 JJ; 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, JJ; 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 Qualifications Education experience requirements Medical, pharmaceutical,or nature science degree with 8+ years of proven expertise and experience in the pharmaceutical/MedTech industry Minimum of 5 years experience in a position of responsibility within Pharmacovigilance and/or Medical Device Vigilance and Safety In-depth understanding of vigilance systems and processes; experience with Medical Devices legislation and processes Demonstrable insight into the development of regulatory requirements with knowledge of Global aspects of drug/device safety, including international reporting requirements and relevant country-specific variations.Proven leadership and management capability with the ability to simplify complex workflows and manage critical issues in a complex environment.Strong experience in the delivery of high-quality work and ability to operate autonomously as part of a multi-disciplinary team Project Management experience including stakeholder and change management experience.Fluent communication skills in English, any additional languages are very welcomed Other.Ability to connect in a complex and geographically widespread organization, to work effectively with different cultures, and instill a culture of diversity and inclusion Ability to maintain strong open relationships both within an organization and with external authorities Up to 25% travel may be required For more than 130 years, diversity, equity inclusion (DEI) has been a part of our cultural fabric at Johnson Johnson and woven into how we do business every day.Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve.Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.At Johnson Johnson, we all belong.Johnson Johnson is an Affirmative Action and 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,or protected veteran status and will not be discriminated against on the basis of disability.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.Please contact us to request accommodation.
El anuncio original lo puedes encontrar en Kit Empleo:https://www.kitempleo.es/empleo/114418610/associate-director-ipv-affairs-medical-device-lead-yu465-humanes-madrid/?utm_source=html #J-18808-Ljbffr
