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**Job Function: **
Medical Affairs Group
**Job Sub Function: **
Medical Affairs
Job Category:
People Leader
All Job Posting Locations:
Seoul, Korea, Republic of
Job Description:
**About Oncology **
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for Associate Director, Hematology.
[Position Summary]
- Lead the development and implementation of the medical strategy and plan of the assigned therapeutic areas** (Hematology)**, including integrated evidence generation plan (IEGP), integrated evidence dissemination plan (IEDP) and therapeutic area (TA) Integrated Value Team (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 (MA)/Therapeutic Area Lead (TAL)]
- Be responsible for developing and/or reviewing study proposals, reports/manuscripts, and relevant study materials from company-sponsored studies to investigator-initiated studies [Study Responsible physician/Scientist]
- Define Medical Science Liaison (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]
[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) and integrated evidence dissemination plan (IEDP) process with TA cross function teams
- Lead local IEGP discussion to identify the data gaps and key research questions (KRQs) required to support the short-term and long-term TA medical/business strategy
- Represent the country and promote local data/clinical gaps found from IEGP and KRQs to regional TA IVT
- Lead local IEDP discussion with cross-functional teams around how and when we will communicate our local and regional evidence
- Promote coordinated scientific messaging to disseminate compelling communications across all stakeholder interactions via a robust common scientific narrative
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 (KOLs) and a wider group of physicians and customers.
- Leverage relationships with investigators and KOLs 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/MA 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/MA on generating key business questions (KBQs), selecting relevant healthcare professionals (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 (AP)]
- 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 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 Operation team in the oversight of IISs
Local Company-Sponsored Study (CSS)
- Lead and/or 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.
- Review and approve relevant study documents in medical/clinical perspective
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 Global Clinical Operation (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.
- Generate or review and approve 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.
[A Member of MAF Leadership Team]
Support the Country Medical Director in the execution and supervision of all country Medical Affairs activities
Compliance
- Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and Standard Operating Procedure (SOP) 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.
**Requirement **
- At least 2-3 years’ experience in clinical practice or experience in pharmaceutical industry (at least 7 years’, especially including hematology) is preferred
- Understanding of local regulatory policy and industry’s code of practice related to drug registration, pharmaceutical promotion and clinical study.
- 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
#LI-Hybrid
Legal Entity
Innovative Medicine
Job Type
Fixed-term (육아휴직대체인력)
Application Documents
Free-form resume AND cover letter is required (in Korean or English).
Application Deadline
Open until the position is filled.
Notes
- Preference will be given to individuals subject to national veterans’ benefits and persons with disabilities upon submission of relevant documents as per applicable laws.
- Only candidates who pass the resume screening will be notified individually. However, notifications may be delayed due to company circumstances.
- If any false information is found in the application documents, the hiring may be canceled even after the offer is confirmed, and future applications may be restricted.
- Submitted documents will not be returned and will be deleted upon request.
**Required Skills: **
Preferred Skills:
Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Content Evaluation, Developing Others, Digital Culture, Digital Literacy, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, Prioritization of Tasks, Product Strategies, Scientific Research, Strategic Thinking, Team Management