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J&J Family of Companies Country Head GCO Hungary & Romania in Budapest, Hungary

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, and 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. Please visit www.janssen.com for more information.

Country Head GCO Hungary & Romania

Location: Budapest

The Local R&D Head II is accountable for strategic and operational management of clinical research and development activities in mid to large-size country. This leads to successful country execution of all phases of clinical trials, including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures(SOPs), policies, Health Care Compliance(HCC) and local regulatory requirements. The Local R&D Head II shapes and manages local organizational structure to ensure its optimal efficiency and demonstrates an effective issue management with in the country and cross-countries. This role is responsible for line management of Functional Managers and other GCO staff, as required. Ensures alignment of local goals with organizational objectives. Drives innovative solutions and process improvements for the country/region or GCO/Global Development (GD) overall.

The responsibilities & the impact YOU will have:

  • Define and implement term strategy and Janssen R&D strategies to position the country for success.

  • Accountable for attracting, planning, execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness.

  • Ensure all objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.

  • Accountable for an appropriate and timely issue customer concern and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach.

  • Primary point of contact for Health Authority agencies for activities related to clinical operations.

  • Country legal representative for GCO related activities (authorized to sign contracts and agreements).

  • Accountable for functional budget and affiliate funding.

  • Shape and maintain strong relationships within GD and Local Operating Company (particularly with Medical Affairs). Might participate in Local Management Board and Regional Management Teams.

  • Develop country capabilities for effective study placement.

  • Oversee selection of sites to deliver on country commitments and strategic goals.

  • Ensure the country compliance with quality and operational metrics. Lead regular metrics review and vital follow-up actions.

  • Contribute to development of new processes and standards to improve clinical trial management as well as lead their rollout.

  • Ensure compliance to safety reporting requirements.

  • Foster a culture of continuous improvement and innovation.

  • Contribute to shaping environment for clinical trials in the country (e.g. through involvement in pharma industry associations).

  • Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.

  • Evaluate and forecast overall resource needs for the country.

  • Ensure understanding of relevant processes and procedural documents supported by documentation of staff training compliance as required.

  • Lead organizational changes and effectively communicate on priority shifts.

  • Review and approve expenses in compliance with the company policies.

  • Strongly demonstrate leadership behaviors in alignment with J&J Leadership Imperatives.

  • Foster an environment that encourages sharing of ideas, information and best practices.

Qualifications

We would love to hear from YOU, if you have:

  • Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). Advanced degree in a scientific discipline and/or Master’s degree is preferred.

  • Minimum of 10 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.

  • Excellent communication and leadership skills. Proven ability to foster team productivity and cohesiveness. Ability to manage complexity under pressure. Proven track record of people and project management. Strong in hiring, training, developing and evaluation of leaders and people managers. Strong decision-making and financial management skills. Flexibility to work in a rapidly changing environment with the appropriate sense of urgency. Experience in transforming organizations in response to business needs.

  • Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required. Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations. Ability to synthesize and evaluate data generated from various reports and sources. Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities. etc.). Influential in improving the clinical research environment at a country level. Visionary leader who can shape the organizational culture to improve adoption of future state.

  • Operates with limited supervision.

  • Proficiency in English. Computer literacy. Strong interpersonal and negotiating skills. Excellent organizational skills and ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.

    This is what awaits YOU at J&J:

  • An opportunity to be part of a global market leader.

  • A dynamic and inspiring working environment.

  • Many opportunities to work on challenging projects and assignments.

  • Possibilities for further personal as well as professional development.

  • Many employee benefits.

    For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

    We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

    That is why we in Johnson & Johnson are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

    Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

    We would love to hear from YOU, if you have:

  • Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). Advanced degree in a scientific discipline and/or Master’s degree is preferred.

  • Minimum of 10 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.

  • Excellent communication and leadership skills. Proven ability to foster team productivity and cohesiveness. Ability to manage complexity under pressure. Proven track record of people and project management. Strong in hiring, training, developing and evaluation of leaders and people managers. Strong decision-making and financial management skills. Flexibility to work in a rapidly changing environment with the appropriate sense of urgency. Experience in transforming organizations in response to business needs.

  • Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required. Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations. Ability to synthesize and evaluate data generated from various reports and sources. Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities. etc.). Influential in improving the clinical research environment at a country level. Visionary leader who can shape the organizational culture to improve adoption of future state.

  • Operates with limited supervision.

  • Proficiency in English. Computer literacy. Strong interpersonal and negotiating skills. Excellent organizational skills and ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.

    This is what awaits YOU at J&J:

  • An opportunity to be part of a global market leader.

  • A dynamic and inspiring working environment.

  • Many opportunities to work on challenging projects and assignments.

  • Possibilities for further personal as well as professional development.

  • Many employee benefits.

    For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

    We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

    That is why we in Johnson & Johnson are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

    Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Primary Location

Hungary-Budapest-Budapest-

Organization

Janssen-Cilag Kft. (8396)

Job Function

R&D

Requisition ID

2105987860W

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