Emea Medical Advisor Mood Disorders

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 EMEA 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”

Specific purpose of the job:
This is an EMEA Medical Advisor role for Esketamine with a clear focus to serve as the Study Responsible Physician (SRP) for the ECHO and ECHO-D Studies

Overall purpose of job:
To enhance the collaboration, support, and communication between the Regional Medical Affairs Team for a specific product or group of products and a specific group of Operating Company Medical Affairs Teams.

To build up or enhance a trusted collaboration with the external scientific community in order to facilitate a continuous communication and transfer of knowledge between the company, thought leaders and a wider group of physicians and customers.

To support the implementation of activities as outlined in the EMEA Medical Affairs Product Plan across EMEA under the guidance of the EMAD in close cooperation with operating companies, and other EMEA functions (EMEA Medical Affairs Program Lead [EMPL], Scientific Knowledge Management [SKM], Medical Education Scientific Relations [MESR], Regulatory Affairs, Marketing, Health Economic and Market Access [HEMAR])

To input into the development of the EMEA Medical Strategy and the EMEA Medical Affairs Product Plan (MAP Plan) for a specific product or group of products in line with Global strategy and in alignment with the Integrated Brand Value Team (IBVT) strategy, taking into account both the weighted needs of the EMEA countries and feedback from the external scientific communities/thought leaders.

To support, as a core member of the EMAP team and the functional network, effective communication between the key internal regional and local groups.

To act as a medical and technical expert.

To represent the unified EMEA MAF voice towards key internal and external stakeholders.

Main activities/ tasks:
Study Planning and Execution
- Support EMAD and OpCos Medical Affairs to evaluate Investigator Initiated Study (IIS) proposals for scientific soundness and whether those are in alignment with the medical strategy
- Support EMAD in all the Company Sponsored Studies (CSSs) activities (safety issues and signal detection review, and follow up the study milestones until publication plan execution).
- Support all Early Access Programs (EAPs) related activities. Give input and actively support the Program Leader Support Investigator Initiated Studies (IIS), by interactions with Investigators, respecting the internal procedures, and monitoring of the milestones planed in the agreement
- Work with and support the EMPL and GCOMAO in the oversight of IIS according to internal procedures including Janssen Standard Operating Procedures (SOP) and Health Care Business Integrity (HCBI), and legal regulations
- To act as Study Responsible Physician (when the Medical Advisor is a qualified medical doctor) or Study Responsible Scientist

Specific responsibilities related to the ECHO and ECHO-D SRP task include:

- responsible for medical oversight and all clinical aspects of the clinical trial
- Works on potential study protocol amendments and takes ownership of clinical study reports and other related documents
- Evaluates adverse events for relationship to treatment
- Assists to Regulatory Affairs submissions and communications and determining requirements for any corrective actions or health authority reporting
- May act as a medical contact of the company for health authorities concerning clinical/medical issues
- Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions

EMEA Medical Affairs Product Team Core Membership
- To act as a EMEA MA expert and input into the strategy for a specific product or group of products:

- Represent EMEA voice towards internal and external stakeholders
- Develop and maintain detailed knowledge in products, market trends, competitor activities etc.
- To provide expertise to the Medical Affairs Functional Network
- To provide expertise to Operating Company functions (CVTs, Medical, Commercial, HEMAR Regulatory Affairs etc.)
- To have a proactive role in the EMEA Medical Affairs Product Team (EMAP team: EMEA Medical Program Lead (EMPLs), MES