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Medical Affairs Group

[Janssen] Immunology TA Lead

  • 标题 [Janssen] Immunology TA Lead
  • 功能 Medical Affairs Group
  • 子功能 Medical Affairs
  • 类别 Senior Manager, Medical Affairs (PL8)
  • 工作地 Yongsan-gu, Seoul, Korea, Republic of
  • 发布时间
  • 申请ID 2406185393W
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描述

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in pharmaceutical, medical devices and diagnostics markets, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. 
Learn more at  https://www.jnj.com/ .

1. 포지션: MAF - Therapeutic Area Lead - Immunology
2. 계열사: 한국얀센
3. 근무지: 서울시 용산구
4. 근무 형태: Regular

[Summary]

   Lead the development and implementation of the medical strategy and plan of the assigned therapeutic area, including integrated evidence generation plan (IEGP) and TA IVT strategy, via close collaboration with internal/external stakeholders and alignment with the global/regional TA medical strategy as well as TA business strategy. and review medical/ promotional materials within assigned therapeutic areas [Medical Advisor/Therapeutic Area Lead]

   Be responsible to review study proposals and reports/manuscripts from Company sponsored studies to investigator-initiated studies [Study Responsible Physician/Scientist]

   Define MSL strategy aligned with brand strategy based on generated medical insights and Lead MSLs to ensure full implementation of medical plans by coaching and supporting [MSL Manager]

[Main responsibilities]

Medical Advisor/Therapeutic Area Lead for assigned TAs

Act as a Medical Affairs Expert and lead the development and implementation of the medical strategy for a specific product (group of products) or franchises

•        Develop and maintain deep knowledge in products, market trends, competitor activities etc.

•        Develop Medical/Brand strategies aligned with company strategy

Provide expert medical leadership for other internal functions (Medical, Commercial, Regulatory affairs, Market Access etc.)

•        Provide consultation to Medical Information for the assigned therapeutic areas

•        Provide expert medical leadership into issue management (e.g. product withdrawals, safety alerts etc.)

•        Provide input to 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

•        Act as a medical representative in meeting with government affairs, such as HIRA and MFDS upon a request of regulatory affairs or market access

Lead integrated evidence generation plan (IEGP) process with TA cross function teams

•        Lead local IEGP discussion to identify the data gaps and KRQs required to support the short-term and long-term TA medical/business strategy

•        Represent Country and promote local data/clinical gaps found from IEGP and KRQs to regional TA IVT (Integrated Value Team)

Build-up and maintain External Relationships

•        Build up or enhance a trusted collaboration with the external scientific community in order to facilitate a continuous communication and transfer of knowledge, from key opinion leaders and a wider group of physicians and customers.

•        Leverage relationships with investigators and key opinion leaders to gain input into the development of the product strategy and to specific protocols.

Coach and support Medical Events

•        For Medical Education activities, support the MSL/Medical Advisor on Medical Education programs concept, review the program proposals and final program outline and support the review of scientific Medical Education materials

•        For medical consulting events including Advisory Board Meetings or consulting with KOLs, Lead or support the MSL/Medical Advisor on generating Key business questions, selecting relevant HCPs with reviewing proposals and final outlines and review of scientific materials

Support and review science of company materials

•        Review promotional materials with ensuring brand 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.

•        Support and review Materials for patient support/education and for Medical Affairs (slide decks, Q&A...)

Collaborate with other regional/countries (Medical/Regulatory Affairs, Market Access in North Asia/Asia Pacific)

•        Work with AP teams to gather local inputs and to drive alignment of strategy/plan for the assigned product plan(s) for designated TAs

•        Act as a co-lead of the Integrated Value Team (IVT)

•        Deliver medical insight into Product Life Cycle Management planning especially for locally developed product when it is applicable.

Study planning and Execution [Study Responsible Physician/Scientist]

Investigator-Initiated Study (IIS)

•        Support Medical Affairs to evaluate proposals of IISs for scientific soundness and whether those are in alignment with the medical strategy.

•        Work with and support Clinical Research team and GCO -MAO team in the oversight of IISs

Local Company-Sponsored Study (CSS)

•        Support the development of country specific study proposals for post registration local studies

•        Participate in study planning, e.g., with respect to evaluation of local business needs, timelines, grants and investigator/ site selection

•        Participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.

•        Support Clinical Operations, when needed, to address any questions and/or clarify issues arising during the conduct of studies.

Global Development Program

•        Provide local country feasibilities for global R&D programs, such as epidemiology, current clinical practice, on-going competitor studies etc. upon a request of GCO

•        Recommend relevant investigator sites considering available patient pools, site capabilities and future company business plans

•        Visit investigators for boosting enrollment, issue management etc. upon a request

Publication

•        Support the development and implementation of the publication plan at local level.

•        Review and approval manuscripts

•        Support efforts that ensure that J&J guidelines for publication of studies are followed, and that all MAF studies are published in accordance with J&J policy.

MSL Manager

Define MSL strategy within Medical Affairs and Lead MSLs to ensure full implementation of the Medical Plans

Strengthen external customer management in the field by building up the capability and capacity of MSLs to ensure high quality scientific engagement

Coach MSLs to develop strategic partnership with internal stakeholders via generated medical insights

Enhance the cross-functional collaboration between MSLs and all stakeholders.

Ensure strict medical compliance in MSL daily activities.

Coach and support individual MSL for best performance and career development.

•        Recruit and establish a qualified MSL team

•        Provide continuous coach to MSLs to ensure the MAF competencies and effectiveness towards team and individual goals

•        Inspire and motivate them by active, open and constructive communication

•        Coach and support them for desired

A member of MAF leadership team

•        Support the Country Medical Director in the execution and supervision of all country Medical activities

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 relevant quality, medical, HCC and legal compliance requirements are fully understood, appropriately managed and complied with when planning projects, developing materials, executing projects and contracting vendors.

[Qualifications:]

Education: Advanced degree in Master of science and above (PhD, MD, or PharmD) is preferred with a major of pharmacy, medical or life science, Medical Doctor is preferred

Related experience:

•        At least 2-3 years’ experience in clinical practice or at least 7 years’ experience in pharmaceutical industry is preferred.

•        Understanding of local regulatory policy and industry’s code of practice related to drug registration, pharmaceutical promotion, and clinical study.

Job specific competencies/skills required :

•        In-depth scientific and/or therapeutic knowledge, strength in research and interpretation of scientific publications

•        Knowledge for research, clinical trial design and process

•        Knowledge of national healthcare and access system

•        Excellent English language skills, spoken and written

•        Interpersonal and communication skills to effectively interact with a broad range of external and internal personnel.

•        Must be familiar with Microsoft Word, Excel and PowerPoint

•        Awareness of, and adherence to, Johnson & Johnson Credo values and International Health Care Business Integrity Guide

The role involves extensive interactions with:

•        Externally, Health Care Professionals

•        Externally, Academic Society

•        Health Care Compliance/ Legal

•        Brand team in local/regional operation

•        Regulatory Affairs and Market Access in local and regional operation

•        Global Clinical Operation/ Medical Affairs Operation (GCO/MAO)

•        All Medical Team leaders and members in local/regional/global operating teams

[JD  확인 및 지원 방법]
www.careers.jnj.com -> Requisition number “ 2406185393W ”검색 -> 해당 모집 공고 클릭 후, “Apply Now”

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