Medical Affairs Lead

The Country Medical Affairs Head is responsible for leading and managing the medical affairs function, covering Janssen business, within the countries. The position is a member of the country management team and plays a major role in providing medical and scientific inputs and comments on company business plans, business issues, crisis management and other quality and compliance issues arising.

The position is responsible for developing and implementing a robust medical strategy and plan that (i) at the disease level, aims to improve standard of care (by enhancing awareness for the disease and unmet medical needs amongst treating physicians, by advocating for quality medical practices amongst treating physicians, policymakers and payers, and by effectively contributing to closing of practice gaps), and (ii) at the asset level, aims to enable full understanding of a brand's differentiated value at launch, and ensuring its safe and appropriate use (by means of data generation, data understanding, data packaging, data dissemination, and by implementing a robust patient / consumer safety vigilance plan).

The position is responsible for ensuring that all medical activities are compliant with country legislation, company policies and procedures, are consistent with the JNJ Credo, and comply with Health Care Compliance rules.
• Responsibilities:
• Integrate Medical Insights into Medical Planning and Operating Company Strategic Planning
• - Design, develop and implement Medical Country Strategic Plans in alignment with Company Objectives, with reference to global and regional strategic direction as well as the intelligence collected from relevant external stakeholders.
• Develop and maintain a scientific network with key thought leaders, advisors and the local scientific community to obtain key insights and to develop strategic partnerships
• Participate in the overall country strategic and annual business planning and resource allocation process.
• Be responsible for monitoring medical spending and project costs.
• Lead the Country Medical Operation
• - Lead and hold accountability for the execution of medical plans to support disease and product/brand objectives.
• Accountable for the internal review and governance of Company and Investigator Initiated Studies
• Accountable for medical approval of all public presentation, media, and core brand related promotional materials to ensure scientific validity and compliance with relevant internal and external standards
• Provide Practical, Evidence-based Expert Opinion on medical and scientific matters
• - Provide scientific and medical insights into relevant Leadership Team meetings
• Provide expert medical opinion into regulatory submission strategy and execution
• Provide expert medical input into company crisis management
• Partner with Business Leaders in developing and deploying Practical and Innovative Evidence-based Solutions to Facilitate Stakeholder Adoption of innovative medicines
• - Lead and participate actively in collecting accurate information on customer needs
• Collaborate with appropriate business leaders in developing relevant customer centric strategies and solutions
• Identify and develop relevant capabilities that support and help sustain strategic initiatives, (e.g., training, curriculum development, learning development programs)
• Develop relevant metrics that facilitate troubleshooting and optimization of deployment of strategic initiatives
• Collaborate with other Medical Directors and / or Medical Affairs Directors to foster exchange of best practices
• Be Responsible for People Development and Management
• - Responsible for the hiring of appropriately qualified medical staff, and the development, implementation, and monitoring of their personal development plans to continuously build capabilities, TA's and brands.
• Build a team culture of high performing, engaged medical experts.
• Work with HR to implement and drive team performance metrics
• Coordinate and strengthen medical interactions with other functional teams
• Ensure External and Internal Compliance
• - Drive compliance through understanding, implementation, and adherence to HCBI, global/regional/local SOPs, GSQA, local regulatory policy and industry codes of practice
• Oversee the Operation of Patient Safety
• - Collaborate with the LSO team to ensure timely safety reporting throughout the life cycle of the products according to company requirements and local regulations
• Qualifications
• :
• Scientific Medical Degree, PhD, PharmD or equivalence required.
• At least 8-10 years' experience in Medical Affairs/medical function is required.
• Proven track record of ability to work within a matrixed organization.
• Deep understanding of local regulatory policy and industry's code of practice related to drug registration, pharmaceutical promotion, and clinical study.
• Expertise in ICH Good Clinical Practice
• Track record of leadership across the medico-marketing in