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Dir. Medical & Regulatory Excellence
Requisition ID: 1805624040W
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases, and vaccines, cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson (J&J). Please visit http://www.janssen.co.uk/ for more information.
Leadership of the operational Medical Affairs and the Regulatory & Medical Compliance divisions, which comprises of the department of Regulatory & Compliance, Medical Information, Medical Evidence Generation and the MSL Coach.
Functional management through indirect reporting lines of the Dept. for Drug Safety & Local Safety Officer, the Dept. for Business Quality Controls and Global Clinical Operations (when medical affairs studies are involved).
Holds primary responsibility for the strategic direction, tactical management and operational excellence and functional alignment of these departments.
To drive consistency and alignment of activities within the UK with the objective of improving the quality of MAF activities and enhancing effectiveness, adequate performance measurements, competency building and compliance.
- To enhance connectivity and best practice sharing across TAs, across product teams within a TA, towards the regional European Medical Affairs team, and other G5 countries.
- To determine the Key Performance Indicators and measure operational efficiency and productivity of the department including the MSLs and MEMs, in close collaboration with the business intelligence team.
- Ensure training and competency enhancement processes are developed and executed for the Medical Affairs function including the MSLs.
- To drive resource and budget transparency and effective utilization across the Medical Department.
- To attract, develop and manage core talent, and build medical affairs operations skills to help create a diverse, high performing team.
- To ensure the provision of high quality Medical Affairs activities including Evidence Generation and Medical Information, Scientific Communications, Medical Education and Medical Compliance in support of strategic objectives.
- Act as a representative of the Country Medical Director in their absence or when delegated as agreed.
- Play an active leadership role in the Business Unit Leader Forum, PRP and Ops committee .
Experience and Qualifications
- Previous experience of medical affairs industry experience in relevant roles
- Strong background in either regulatory, drug safety, clinical trial operation and conduct, medical affairs or quality
- Several years of project management expertise; formal training and certification is a plus
- Previous experience of line leadership experience
- Proven ability to manage cross-functional teams in a highly complex matrixed organization
- Formal pharmaceutical (pharmacist) or medical education (physician, nurse) are a plus
- Formal scientific training with MBA or PhD qualifications are a plus
We respectfully request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Janssen-Cilag Ltd, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
United Kingdom-England-High Wycombe
Janssen Cilag Ltd. (7360)