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EMEA Medical Affairs Director (EMAD) - Oncology
Requisition ID: 00001BDI
Overall purpose of the job
EMEA Medical Affairs Product Leadership
- To act as the EMEA MA expert and drive the strategy for a specific product or group of products:
- articulate the consolidated medical voice for EMEA
- represent EMEA voice at regional and global teams (IBVT, GMAT, lifecycle teams)
- develop and maintain detailed knowledge in products, market trends, competitor activities etc.
- Buildup/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 EMEA functions (Medical, Commercial, Health Economics, Regulatory Affairs etc.) and functional network in the countries
- To represent EMEA MA for specific product or group of product at IBVT, which includes shaping the brand strategy andproviding input into the development of the EMEA plan ensuring alignment with the IBVT strategy
- To oversee the EMEA Medical Affairs budget for pan-EMEA activities for assigned product(s) for which EMAD is accountable.
- To lead the EMEA Medical Affairs Product Team (EMAP team: EMEA Medical Program Lead (EMPLs), MESR (Medical Education Scientific Relations, SKM (Scientific Knowledge Management) and the Medical Affairs functional network to deliver 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) according to the EMAP Team charter
- Draft the EMEA Medical Affairs Product Plan for allocated product(s) and drive the review and approval process with the EMAP team, EMEA Therapeutic Area Team (ETAT), the EMEA Medical Affairs Leadership Team (EMALT) and IBVT
- Work with the EMAP Team to proactively identify and provide medical input into opportunities for new indications or lifecycle extensions for allocated product(s)
- Work with the EMAP Team to develop approaches to support successful market access for allocated product(s) in partnership with Health Economics, the CDT (Compound Development Team) and lifecycle management teams
- Leverage product(s) expertise, medical and market insight to shape and direct implementation of product(s) strategies and plans
- Work with the EMAP Team and Medical Affairs functional network to drive the implementation of the Strategy and Plan
- Ensure effective and regular communications between Global, Regional and local MA teams, including regular communications to help minimize duplication of clinical, advocacy and access programs across countries, and facilitate co-ordination between EMEA Medical Affairs, CDT, Strategic Marketing, Health Economics and individual countries
- Being a member of the GMAT:
- To represent the unified EMEA voice,
- To shape Global MA Strategy, both for the product and the Global TA strategy
- To input into the Compound Development Team (CDT), including input into phase II/ III designs, and country and site selection
- To input into the Global Clinical Program with the aim to reach alignment and avoid duplication or conflicting clinical projects
- To provide input on the breakthrough research in line with the unmet medical/social needs in EMEA region
- To provide input into phase I designs
- To provide input into publications plan
- and into Medical Educations plan/activities on EMEA soil
- Accountable for line managing EMEA Medical advisors (if applicable):
- Allocation of responsibilities for product ownership and other activities
- Objective setting
- Performance management and performance evaluation
- Coaching and feedback outside of the formal performance management processes
- Ensure that appropriate training (e.g. internal seminars) in core EMAP Team, Medical Affairs, functional skills, Good Clinical Practice (GCP) and required SOPs is undertaken
To maintain and leverage relationships with investigators, EMEA thought leaders and patient groups to gain input into the development of the product strategy, to specific protocols, and to services ensuring high-quality disease care.
Product Safety and Regulatory Requirements
- As per the J&J guidance and SOPs:
- Manage Product-related medical safety issues and provide input to the PV EMEA Pharmacovigilance & Medical Compliance, Janssen EMEA Medical Affairs and Safety Management Teams (SMTs).
- Work with Regulatory Affairs & Product Issue Management Team to coordinate and manage Product-related Issues and support major quality incidents / recalls throughout Janssen EMEA
- Escalate issues and enquiries to ETAL responsible for specific products as appropriate
- Provide requested information as specified in the Call For Information (CFI) distributed by GMS, during the initiation of Periodic Safety Update Reports (PSUR),
- Responsible, as Study Responsible Physician, for the writing and the quality of the Study Specific Safety Summary for pan-EMEA studies, per ASR guidance and the J&J template. Also, responsible for ensuring that ASR reporting to the Competent Authorities and IECs for IMPs with existing ASR schedules is compliant with the procedures and SOP’s.
- Provide clinical input to CCDS or SmPC update process and where appropriate ensure development and approval of clinical overview.
Study Planning and Execution
- Ensure that all EMEA MA protocols (pan EMEA and single country) are in alignment
with, and support, the medical strategy:
- Work with the EMAP team to define pan-EMEA study concepts
- Develop scientific content for pan-EMEA protocols and give guidance to the
design of local studies as appropriate
- Accountable for having pan-EMEA study concept and protocols approved per defined timelines, with the support of the appropriate EMPL, including HEMAR activities, collecting patient level data, translation research activities.
- Accountable for the regional review of study concept (ReCAP process) for local studies
- Review and approve single country interventional protocols per EMEA PRAP process
- Get input from GDO/GCO
- For pan-EMEA studies, act as Study Responsible Physician (SRP) or oversee the SRP and ensure they follow EMEA Medical Affairs Study Planning and Execution SOPs Align country selection with IBVT strategy
- Work with the EMPL and GCO to support them in the timely, and within budget, execution of pan- EMEA studies in accordance with current SOPs
- Provide medical oversight for the identification and feasibility analysis of countries and investigational sites
- Provide scientific input into the generation of the ethics/regulatory submission documents and provide responses to ethics committee/regulatory authority questions, to facilitate regulatory / ethics approval
- Provide medical input into the trial CRF development /database set-up
- Conduct a medical review of, and approve the clinically-related study materials (e.g. patient alert cards)
- Provide medical content input to the preparation of study specific training materials for monitors, investigators etc.
- Provide strategic direction and guidance to the development of the Statistical Analysis Plan, top line statistical analysis results and final statistical analysis package
- Accountable for Final Study Report for pan-EMEA studies
- Coordinate the review of the clinical study report with scientific committees, work to finalize the report and gain internal approval to publish
- Work to ensure that the Clinical Study is published and in accordance with the applicable publication SOP/procedures.
- Develop and disseminate an EMEA MA publication strategy (as part of the MA Strategy and Plan for allocated product(s), in alignment with the Global publication strategy).
- 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.
- Work with the designated MESR (Medical Education Scientific Relations) to integrate and align medical education plans and budgets with the EMEA MA Strategy and Plan for allocated product(s)
- For pan-EMEA Medical Education activities, agree with the EMEA MESR (Medical Education Scientific Relations) on Medical Education programs concept, review the program proposals and final program outline (e.g. ensure final agenda is aligned with company strategy and latest knowledge on company products) and review scientific Medical Education materials in collaboration with SKM (e.g. review data accuracy on J&J products)
- Approval of Pan-EMEA Medical Education activities
Scientific Knowledge Management (SKM)
- Review and approve the content of EMEA Core Medical Information Responses (EMEA CMIRs) once drafted by the SKM (Scientific Knowledge Management) Product Specialists and Virtual Teams
- Work with designated EMEA SKM (Scientific Knowledge Management Product Specialist (s) to integrate and align Medical Information requirements with the EMEA MA Strategy and Plan
- Act as expert resource, providing input to responses to complex medical information enquiries
External communication team
Review and approve the content of EMEA communication released once draft by the communication team
Promotional and market research Materials
- Medical review and approval of marketing materials (e.g. detail aids)
- Medical review and approval of market research materials
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.
- Fluency in English language required
- Fluency in additional EMEA languages an advantage
- Able to accommodate substantial travel
- EMEA Medical Affairs Strategy and Plan
- Line Management of Medical Advisors
- Product budget for pan-EMEA MAF activities
- Study Specific Summaries of pan-EMEA studies for Annual Safety Reports
- Sign off on Protocols for pan EMEA
- Review and approve single country interventional protocols
- Final Study Report for EMEA MA Studies
- Product EMEA MA Publication Strategy
- Review and approval of product EMEA Medical Education Programs and scientific materials
- Sign off on EMEA Core Medical Information Responses (CMIRs)
- Medical review and approval of market research and promotional materials
OTHER FEATURES OF THE JOB:
Definition of reporting lines:
Janssen EMEA Therapeutic Area Leader (solid line)
- ETAL provides functional line management to EMADs including performance review, priority and objective setting.
- In-depth knowledge with at least one 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 (e.g. statistical analysis)
- Good knowledge of EU CTD and GCP requirements
- 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
- Strong leadership skills, capable of driving a multi-cultural, virtual team
- Very strong and demonstrable communication and influencing skills that can impact at a Regional and Global level
- Awareness of, and adherence to, Johnson & Johnson Credo values
- Scientific or Medical degree and higher medical qualification essential
- 2+ years’ experience in clinical medicine in an area relevant to the TA
- 5 + years industry / business experience with a minimum of 2 years’ experience in a relevant area for this function (e.g. Medical Affairs or Clinical R&D)
- 1 – 3 years’ project management, team leader or functional line management experience
Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa, 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)