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 Innovative Medicine and MedTech, 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
Job Function:
Medical Affairs Group
Job Sub Function:
Medical Affairs
Job Category:
Scientific/Technology
All Job Posting Locations:
Seoul, Korea, Republic of
Job Description:
About Innovative Medicine
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.
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
Position summary
- Be responsible for the overall process for local study, from ideation, execution, and publications and for oversighting an investigator-initiated study (IIS) [Study Responsible Scientist/physician].
- Lead developing and implementing the medical strategy and plan of in-market products and pipeline by the assigned therapeutic area(s), including IEGP, IEDP, 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. [Medical Strategic leaders].
- Define MSL strategy aligned with medical/brand strategy based on generated medical insights and Lead MSLs to ensure full implementation of medical plans by coaching and supporting [MSL Manager].
[Study Responsible Physician/Scientist]
Lead Local Company-Sponsored Study (CSS)
- Lead ideation and planning local study based on defined local data gaps via collaborating with RWE team, e.g., with respect to evaluation of local business needs, timelines, grants and investigator/ site selection.
- Support RWE and MADU team in study execution, e.g. study start-up meetings and other activities to provide the appropriate training and information to investigators and other site personnel.
- Contribute to review study results and lead publications based on KRQ and medical insights.
Consult Investigator-Initiated Study (IIS)
- Support MSL(s) to evaluate IIS proposals for scientific soundness and whether those are in alignment with the medical strategy.
- Work with and support MADU team in the oversight of IISs’ execution.
Support Global Development Program to ensure that J&J guidelines for publication of studies are followed, and that all MAF studies are published in accordance with J&J policy.
- Provide local country feasibilities for global R&D programs, such as epidemiology, current clinical practice, on-going competitor studies etc. upon the 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.
[Medical strategic leader for assigned disease area(s)]
Medical Strategic Leader to develop and implement the medical strategy for in-market product(s) and upcoming product(s) based on the field medical insights and tight collaboration with internal stakeholders.
- Develop Medical/Brand strategies aligned with Regional/Global medical strategy.
- Lead local Integrated Evidence Generation plan (IEGP) and integrated Evidence dissemination plan (IEDP) aligned to WW MAS/IEGP through identifying data gaps and KRQs.
- Lead or support MSL(s) to execute medical events including Medical educational symposium (ME), Advisory Board Meeting (ABM), Individual consulting.
- Co-lead for integrated value team (IVT) in assigned Das.
Medical leader for tight collaboration with internal stakeholders in local and regions (North Asia, Asia Pacific, Global), including other MAF functions, and others including Commercial, Regulatory affairs, Market Access, etc.
- Provide Medical expertism in issue management (e.g. product withdrawals, safety alerts, etc.).
- Provide medical inputs to business development initiatives for relevant product(s) or pipeline(s).
- Work with regional MAF team to provide local inputs and to drive alignment of strategies/plans for assigned product(s) and DA(s).
- Act as a medical representative in meeting with government affairs, such as HIRA and MFDS upon a request for regulatory affairs or market access.
Medical leader for External Relationships
- Build up or enhance a trusted collaboration with the external scientific community to facilitate continuous communication and transfer of knowledge, from key influencers (KIs) and a wider group of health care professionals (HCPs).
- Leverage relationships with local investigators and Key influencers (KIs) to gain input into the development of the product strategy and to specific protocols.
Medical Reviewer for company materials including promotional/medical materials and other educational materials with scientific view.
[MSL manager]
Define MSL’s field 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 coaching 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 performance and career development.
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:
- Advanced degrees (Master of science or above (PhD, MD, or PharmD)) and major of pharmacy, medical, or life science is required.
- At least 1-2 years’ experience in clinical practice or at least 5 years’ experience in the pharmaceutical industry is preferred.
- Previous experiences of medical role in oncology in global pharma industry are highly 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.
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.
#LI-Hibrid
Legal Entity
Innovative Medicine (Formerly Janssen Korea)
Job Type
Regular
Application Documents
Free-form resume AND cover letter is preferred (in Korean or English).
Application Deadline
Open until the position is filled.
Required Skills:
Preferred Skills:
Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Compliance Management, Consulting, Content Evaluation, Critical Thinking, Developing Others, Digital Culture, Digital Literacy, Healthcare Trends, Medical Affairs, Medical Communications, Medical Compliance, Organizing, Product Strategies, Stakeholder Engagement, Strategic Thinking
