EMEA Medical Advisor Hematology

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”! The EMEA Medical Advisor (MA) is a core member of the EMEA Medical Affairs Product team and ad hoc member of cross-functional IBVT team. The individual is a product/ therapeutic area expert to provide in depth TA expertise to the IBVT. In addition to support the execution of IBVT strategies, the MA also supports the creation of Medical Affairs and evidence generation strategies under supervision of IBVT. Core tasks are to provide medical leadership and subject matter expertise to external and internal stakeholders, leading evidence generation and publication strategy, medical and scientific education / communication. 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, global partners and local 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 other healthcare professionals To actively contribute to the development of the EMEA Medical Strategy and the EMEA Medical Affairs Product Plan (MAF Plan) for a specific product or group of products in alignment with the Integrated Brand Value Team (IBVT), providing input into the Global strategy, taking into account both the weighted needs of the EMEA countries and feedback from the external scientific communities/thought leaders. To lead the implementation of activities as outlined in the EMEA MAF Plan across EMEA under the guidance of the EMEA Medical Affairs Director (EMAD) in close cooperation with operating companies, and other EMEA functions (EMEA Medical Advisors for the respective compounds, EMEA Medical Affairs Program Lead [EMPL], Scientific Knowledge Management [SKM], Medical Education Scientific Relations Lead [MESRL], Regulatory Affairs, Marketing, Health Economic and Market Access [HEMAR]). To support, as an ad hoc core member of the IBVT and core member of the functional network, effective communication between the key internal regional and local groups. To support the EMAD in the oversight of the EMEA Medical Affairs budget for the assigned activities/product(s). To act as a medical and technical expert. To represent the unified EMEA MAF voice towards key internal and external stakeholders. MAIN ACTIVITIES/TASKS: EMEA Medical Affairs and ad hoc Core IBVT Membership To act as a EMEA MA expert and input into the strategy for a specific product and disease area: Represent EMEA voice towards internal and external stakeholders; Develop and maintain detailed knowledge in disease areas, products, market trends, competitor activities: Build-up/maintain network with external thought leaders to ensure clear understanding of external thinking and ensure external input into product strategies and tactics. To provide expertise to the IBVT / Medical Affairs Functional Network. To provide expertise to Operating Company functions (Core Value Teams [CVTs], Medical, Commercial, HEMAR Regulatory Affairs, etc.). To have a pro-active role in the IBVT, EMEA Medical Affairs Product Teams and Medical Affairs functional networks to provide input into and support the implementation of the EMEA MA Strategy and Plan: Lead and work with the EMAP Teams to gather input for the EMEA Medical Affairs Product Plan(s) for designated product/disease area according to the IBVT charter; Work with the IBVT and EMEA Medical Affairs product teams and functional networks to drive the implementation of the Strategy and Plan; Support effective and regular communications IBVT, product teams and local MA teams, including regular communications to help minimize duplication of efforts across countries, and facilitate co-ordination between EMEA Medical Affairs, Marketing, HEMAR, and individual countries; Develop / provide input into regional and local publications plan; Provide input into Medical Education plans/activities in EMEA region and countries; Support operating companies in developing, aligning, and implementing their product strategies and tactical plans. To ensure MAF lead at IBVT under supervision of EMAD: To support IBVT on business and MAF strategy creation and tactic execution; To support MAF brand team budget management. External Relationships 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 leverage relationships with investigators, EMEA thought leaders and patient groups to gain input into the development of the product strategy and to specific protocols. To lead on creation and maintenance of regional external engagement plan. Product Safety and Regulatory Requirements As per the J&J guidance and SOPs, provide assistance to the EMAD in the execution of selected activities. Study Planning and Execution Develop the overall evidence generation strategy for EMEA in collaboration with product EMEA teams. Support EMEA and local Medical Affairs to evaluate Investigator Initiated Study (IIS) proposals for scientific soundness and whether those are in alignment with the medical strategy. Work with and support the EMPL and GCO-MAO in the oversight of IISs. To act as Study Responsible Physician (when the Medical Advisor is a qualified medical doctor) or Study Responsible Scientist. Publications Development and implementation of the EMEA MA publication plan at regional and local level. Support efforts that ensure that J&J guidelines for publication of studies are followed, and that all MA studies (local and EMEA) are published in accordance with J&J policy. Ensure EMEA messages relating to allocated product(s) (including core medical education materials, abstracts, medical information materials, marketing materials etc.) accurately reflect scientific data and are fully compliant with applicable regulations. Medical Education For pan-EMEA Medical Education activities, support the EMEA MESR (Medical Education Scientific Relations) on Medical Education programs concept, review the program proposals and final program outline and support the review of scientific Medical Education materials in collaboration with SKM. Materials Support review of Medical Affairs Materials (scientific communication platform, slide decks, Q&A). Support cross-functional EMEA team and local OpCo training needs in drug/disease area. Other Activities as Required Provide input and support IBVT to create EMEA business development initiatives for allocated product and disease area. When requested Partner with the late lifecycle management group to provide proactive medical input for lifecycle extension opportunities as appropriate. Liaise with R&D functions as needed and appropriate (e.g., test reagents requests, data requests, etc.). Compliance Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOP’s (Standard Operating Procedures) are met and appropriately managed when planning projects, developing materials, executing projects and contracting vendors. Ensure HCC and legal requirements are fully understood, appropriately managed and complied with when planning projects, developing materials, executing projects and contracting vendors. Qualifications In-depth knowledge with at least one disease area and associated product within TA including main competitors. Excellent knowledge of the TA in general with a good knowledge of all products within TA. In-depth knowledge and hands-on experience of clinical trial design and study data analysis. Good knowledge of EU CTD, GCP requirements and applicable regulations. Good knowledge of study execution, Global Medical Safety and regulatory affairs. Sound knowledge of study publication processes and publications within the TA. Highly customer and market place focused with an awareness of the importance of business results. Innovative with the ability to coordinate and drive a complex and changing environment. Ability to work effectively in a matrix environment. Capable of working in multi-cultural, virtual teams. Very strong and demonstrable communication and influencing skills that can impact at a Local, Regional and Global level. Ability to use professional skills and experience to gain insights into patients and stakeholder needs, leverage these insights to advice business and MAF strategy creation. Awareness of and adherence to Johnson & Johnson Credo values, policies and SOPs. EXPERIENCE: Scientific or medical degree. 2+ years experience in an area relevant to the TA. 5 + years industry / business experience with experience in a relevant area for this function (e.g. Medical Affairs or Clinical R&D). SPECIAL REQUIREMENTS: Fluency in English language required. Fluency in additional EMEA languages an advantage. The role is EMEA based and is likely to involve extensive EMEA and International travel. The role holder will be expected to be based in his/her current country of residence as long as easy access to travel/transportation and local hosting is available at a Janssen office. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location. Primary Location Belgium--- Other Locations Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-Spain, Europe/Middle East/Africa-France, Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa, Europe/Middle East/Africa-Italy Organization Janssen Pharmaceutica N.V. (7555) Job Function R&D Requisition ID 00001ICR