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EMEA Medical Advisor Long Acting Therapies/Schizophrenia (Central Europe)
Beerse, Belgium; Switzerland; Italy; Germany; Spain; France; United Kingdom; Ireland
Requisition ID: 00001C7J
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:
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 Programme Lead (EMPLs), MESR (Medical Education Scientific Relations, SKM (Scientific Knowledge Management) and the Medical Affairs functional network) to provide input into and support the implementation of the EMEA MA Strategy and Plan:
- Work with the EMAP Team to gather input for the EMEA Medical Affairs Product Plan(s) for designated product(s)
- Work with the EMAP Team and Medical Affairs functional network to drive the implementation of the Strategy and Plan
- Active participation to the co-create EMAP Team activities and projects
- Support effective and regular communications between EMAPT and local MA teams, including regular communications to help minimize duplication of advocacy and access programs across countries, and facilitate coordination between EMEA Medical Affairs, Marketing, HEMAR, and individual countries
- Provide input into local publications plan
- Provide input into Medical Education plans/activities in EMEA countries
- Support operating companies in developing, aligning, and implementing their product strategies and tactical plans
- Support and liaise with the EMAD in communication and feedback to Global MAF
- 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.
Study Planning and Execution
- Support 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
- Support the development and implementation of the EMEA MA publication plan at 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.
- 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.
- Support review of Medical Affairs Materials (slide decks, Q&A...)
- Support local OpCo training needs in drug/disease area
Other Activities as Required
- Provide input to EMEA business development initiatives for allocated product(s). 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 (eg pure substances requests, PK data requests etc.)
- Support implementation of the EMEA Medical Affairs Strategy and Plan at local level
- Enhance collaboration with external scientific community (incl. IIS)
- Support OpCos as expert with the implementation of tactical plans
- Support review of product EMEA Medical Education Programs and scientific materials
- Support medical review and approval of market research and promotional materials in accordance with internal procedures and applicable external regulations.
- Fluency in English language required
- Fluency in additional EMEA languages an advantage
- Able to accommodate travel required for the function
Knowledge & skills:
- In depth knowledge with at least one product within Neurosciences including main competitors
- Excellent knowledge of the Neuroscience 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 and GCP requirements
- Good knowledge of study execution, Global Medical Safety and regulatory affairs
- 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 multicultural, virtual teams
- Team player with the ability to work under own initiative
- Self-starting, proactive and innovative
- Very strong and demonstrable communication and influencing skills that can impact at a Local, Regional and Global level and collaborative mind set
- Awareness of, and adherence to, Johnson & Johnson Credo values, policies and SOPs
- Medical or Scientific Degree, PhD, PharmD or equivalence degree
- 2+ years’ experience in Neurosciences
- 2+ years’ experience as a Study Responsible Physician (when the Medical Advisor is a qualified medical doctor) or Study Responsible Scientist
- 2 + years industry / business experience with an experience in a relevant area for this function (e.g. Medical Affairs or Clinical R&D)
- The role is Central EU based and will involve 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.
Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Ireland, Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-France, Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-Spain, Europe/Middle East/Africa-Italy
Janssen Pharmaceutica N.V. (7555)