Compliant Communication Manager EMEA Medical Devices (m/w)

  • Vollzeit
  • D-PLZ 22

Johnson & Johnson MEDICAL GmbH

Im Geschäftsbereich Medical, mit Sitz in Norderstedt, arbeiten Sie an wegweisenden Produkten der Medizintechnik. Im Innendienst leisten Sie einen wichtigen Beitrag dazu, innovative Produkte der Meidzintechnik zu entwickeln und für Patienten und Behandler zugänglich zu machen. 2015-cf_medical-logo.gif

Aufgaben

#Accountability #§§Staff of approximately up to 8 direct reports and sub-teams at multiple J&J Medical Device sites within the EMEA region, UK, Italy, France, Germany. Supervise team of outsourced resources by partnering with outsourced team lead, including hiring and goals and objectives generation. #§§Staffing and development of talent for EMEA Compliant Communication function. Lead recruitment, on-boarding, training/development and succession planning, as well as foster a high performance environment and culture of collaboration and innovation. #§§Serves as a leader on the Global Compliant Communication leadership team, providing insights and process improvements for global strategic business initiatives. #§§Functions as the overall relationship manager for key commercial stakeholders to drive alignment across all MD franchises. #§§Supports sustainable organization through leading functional strategies, developing processes, best in class systems and completing organization design and staffing. #§§Attracts, develops & retains a diverse Compliant Communication team. #Copy Approval Process: #§§Lead the Copy Approval process for EMEA Medical Devices with a continual improvement mindset. #§§Lead initiatives to ensure adherence to consistent standards and practices. Support the updating of standard operating procedures & standards as requirements evolve. #§§Partner with WW Director, Compliant Communication to drive Reviewer effectiveness and efficiency gains (Quality, Regulatory, Medical Affairs, Healthcare Compliance, Legal Affairs). #§§Partner with WW Director WW Compliant Communication to drive submitter effectiveness and efficiency gains (Commercial VP’s). #§§Manage all internal/external compliance audits & manage non-conformance activities such as audit observations/actions & CAPA actions & effectiveness monitoring within the quality systems. #§§Ensure a feasible submission process, moderation of meetings and follow-ups post meetings #§§Partner with Operations Team to determine the metrics that matter and method of measure to provide senior management with process confidence. #§§Execute against the Medical Device digital asset lifecycle management strategy including archival & retirement of non-compliant promotional materials. #§§Benchmark J&J and other industries for Best-in-Class Compliant Communication and CoE practices. Benchmark J&J and other industries for Best-in-Class Compliant Communication and CoE practices. #Litigation Support: #§§Provide compliant documentation in support of litigation, including delivery of archival files. #§§Partner with internal & external litigation attorneys to ensure compliant product communication through multiple channels. #Training and Change Management: #§§Support the training and change management strategy for all new processes related to compliant communication by ensuring all key stakeholders are trained with a focus on continuous improvement. This includes the training of all commercial associates, reviewers and key agency partners on the Copy Approval SOP.

Qualifikationen

#Required: #§§Bachelor’s Degree #§§Business experience (+8 years) with experience in commercial roles in a regulated industry #§§Experience in Compliant Communication (Copy Approval) #§§People management experience #§§Demonstrated knowledge in Legal and Health Care Compliance policies around Promotional Materials #§§Experience in process and compliance audits with internal Quality teams as well as external governing Regulatory and notified bodies. #§§Experience managing audit and CAPA action plans via internal quality systems. #§§Proven leadership ability to effectively motivate and manage a team of professionals, including outsourced resources. #§§Strong interpersonal and collaboration skills with ability to engage with all levels of management #Preferred: #§§Knowledge of J&J and Industry systems such as copy approval, digital asset management and quality management. #§§Experience creating and delivering training to diverse user groups #§§Demonstrated track record for Standards of Leadership traits #§§Awareness of process excellence methodology #§§Involvement in and knowledge of business transformations #OTHER SKILLS AND ABILITIES: #§§High technological and business aptitude #§§Strong influence management and communications skills #§§Demonstrated ability to develop internal and external networks #§§Demonstrated track record for Standards of Leadership traits #§§Must be able to drive success strategically and tactically, leading by example #§§Problem solving/resolution and Cross functional influencing skills #§§Project management experience required #§§Excellent written and verbal communication skills; effective interpersonal and teamwork skills. Die Förderung und Entwicklung unserer Mitarbeiter/innen sind zentrale Werte unserer Unternehmenskultur. Menschen, die in einem internationalen Unternehmen ihre Potenziale entfalten und an ihren Aufgaben wachsen möchten, finden bei uns beste Voraussetzungen. Neben der intensiven Einarbeitung und der bedarfsgerechten Weiterbildung sind hervorragende Entwicklungsmöglichkeiten – national und international – sowie eine attraktive Vergütung und überdurchschnittliche Sozialleistungen wichtige Elemente für unsere Mitarbeiter. Darüber hinaus ist unser Konzern gekennzeichnet durch nachwuchs- und karrierefördernde Maßnahmen im Einklang mit Familie und Beruf. 1 2015-cf_gptw2016.gif 1 2015-cf_company_medical.png