Johnson & Johnson is a leading and one of the largest healthcare companies in the world including three sectors: Pharmaceutical, Consumer and Medical Device & Diagnostics. We are well-known for QUALITY, an achievement brought about by careful planning, a conscious and consistent effort in using advanced manufacturing technology and providing excellent development opportunities for people to attain optimal performance. Our products are recognized in the worldwide market under the brands of JOHNSON's, CLEAN & CLEAR, MODESS, CAREFREE, LISTERINE, BAND-AID, and so on.

 

At Johnson & Johnson, our company's ethical character is defined by our people. We strive to attract people with strong, positive values, and we develop, reinforce and reward those values. Our special set of values is embodied in Our Credo, a respected, legendary document that has guided our company for almost 70 years. As our ethical framework, it outlines our responsibility to our customers, employees, communities and stockholders. As you get to know us, you'll realize that our people choose to live Our Credo - to work at making it vital day-in and day-out - not because it is required, but because it feels right.

 

If you are looking for more than a job, and are inspired by the opportunity to create the future to bring quality of life to the world, we invite you to build your career with us.


Overall purpose of job:

  • Provide scientific support to internal and external customers in response to clinical interest related to responsible therapeutic area/disease.
  • Provide scientific insights, medical gap analysis to internal stakeholders including AP MAF team, local MAF/ME team and commercial partners in order to build and optimise brand/therapy strategy.
  • Support the sharing of knowledge to internal stakeholders e.g. through provision of training to help to ensure highest standards of brand/therapy expertise in customer facing teams
  • Be a scientific responsible party for Medical Affairs Studies
Essential duties and responsibilities:

TA Leadership

  • Be trusted scientific experts in the related TA disease management.
  • Be aware of latest scientific and clinical advances in relevant therapy areas.
  • Know well and skillful in conducting literature search and good ability in reading and analyzing clinical papers to promote evidence/scientific-based brand concepts.
  • Provide regular clinical & scientific knowledge sharing across the TAs and Brands
  • Deliver medical insight into product Life Cycle management planning. Provide Medical expertise to marketing colleagues in product development team from the early development phase throughout the life of the product by identifying the optimum positioning of the product in the life of the therapeutic area.
  • Provide expert medical leadership into issues management (e.g. product withdrawals, safety alerts etc.)
  • Provide expert medical input into key market activities and regulatory body interactions 

Medical Strategy

  • Responsible for developing and implementing medical affairs strategy plan within therapy area thru  effective medical gaps analysis in clinical data, clinical care, knowledge and medical education gaps together with holistic understanding of customers insights (external and internal stakeholders)
  • Partner with medical education team and business partner for excellent execution of medical affairs activities as defined in medical affairs strategic plan

Medical review

  • Responsible for Medical Affairs proactive input into the concept development of Brand promotional materials, artwork and final medical sign off /approval for each brand associated with the therapeutic area, ensuring alignment with Company standards and relevant POL/SOP on medical review
  • Review and approval of promotional material, labelling information, package insert, training material for sales and marketing colleagues or other relevant documents, including reviewing translation medical document when needed.

Medical education activities

  • Identify important medical activities in order to fulfil medical education and knowledge gaps as defined in medical affairs plan
  • Work collaboratively and effectively with medical education team for  development and implementation of all medical education activities including company-organized medical education, CME, educational grants or sponsor HCP to medical education events
  • Take ownership in designing and leading Medical Advisory Boards.
  • Take ownership and proactive approach in working with faculty for ensure high quality of scientific content 

Customer/External Interaction & KOL engagement

  • Develop and maintain scientific relationships with key thought leaders to build customer insight and develop strategic partnerships
  • Meet with customers and researchers on a regular basis through meetings, conferences etc., in order to
    • Gather information and insights on therapy area (inc. Competitor landscape) and their medical and scientific needs
    • Exchange disease area knowledge and opinions in order to understand the emerging opinions
    • Increase the customers understanding of Janssen products and processes (eg. clinical data, IIS, clinical trials, compliance processes), according to their expressed interests and needs and to seek their advice on the development of our products.
    • Manage and maintain positive relationship with Key Opinion Leaders.Deliver scientific and medical content for medical advisory boards and medical education activities.

·        To be the point of contact for investigators proposing investigator initiated studies (IIS) and manage MAF studies (in collaboration with GCO)

  •  As requested business partners (e.g. Public/Communication Affairs, MKT), provide support in interacting with patient advocacy groups and their initiatives e.g. responding to clinical interest, gathering insights
  • Establish and maintain contacts with external experts, participate in advisory committees and other professional relations activities and thought leaders within the territory and other countries where needed.
  • Develop and maintain productive relationships with relevant professional societies

Data generation

  • Work in collaboration with Regional Medical Affairs for post-registration medical data gaps and clinical trial needs and to drive the development of necessary protocols at local level
  • Lead the development of study proposals for post registration company-sponsored local studies
  • Accountable for the internal review and governance of Investigator Initiated Studies (IISs)
  • 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 affiliate Clinical Operations, when needed, to address any questions and/or clarify issues arising during the conduct of studies, including Review and prioritise study protocols in consultation with GCO and Marketing with respect to local marketing goals, scientific merit and GCO resources.  Advise or assist in the preparation of IRB submissions, including adaptation of international patient information sheets and consent forms to suit local requirements ;  Provide liaison between Marketing and GCO , interface with the local medical community both for local purpose (e.g. clinical teams, protocol writing, clinical plan design, brainstorms, advisory groups) and in support of international project.

Medical training

  • Provide Medical and Scientific training for internal stakeholders and external customers if required, including Sale and Marketing Colleagues as well as other relevant department

Other important tasks

  • Provide MAF support in health economics with medical input as appropriate
  • Medical information inquiry responsibility: Respond appropriately to unsolicited requests for information and/or data
  • Be primary contact and responsible for Name Patient Programs conducted locally.

Internal collaboration & support

  • Participate in cross-functional (marketing, medical, regulatory, QA…) and input medical insights in brand team strategies. Additionally, highlight key aspects of the clinical data so that they form the basis of key marketing messages.
  • Engage with internal stakeholders on topics of mutual interest in order to encourage optimal use and/or understanding of Janssen products
  • Build effective cross-functional working way and add value to business by
  • Helping commercial colleagues in handling complex medical questions
  • Field visit as a result of joint MKT/MAF decision
  • Building KOL knowledge


Qualifications
Key compliance requirements

  • Complete annual Drug Safety and HCC Awareness training
  • Report Adverse Events and complaints in a timely way to Drug Safety according to current Adverse Event Reporting guidelines/SOP and to maintain Regulatory compliance
  • Acts in accordance with Johnson & Johnson HCC requirements if interacting with Healthcare Professionals and/or GO.
  • If commissioning contractors or third party organizations, put contracts in place and provide training so that these individuals also act in accordance with Johnson & Johnson HCC requirements when interacting with Healthcare Professionals and report adverse events and complaints (as above).
  • Complies with designated SOP’s for the role 
Core competencies required for this role:

  • Experienced in pharmaceutical industry is preferred
  • Good understanding of clinical studies design and data
  • Fluent English both in writing and speaking
  • Interpersonal communication skills
  • Influence on other skills
  • Strategic thinking mindset
  • Ethical working approach with patient-centric focus


Primary Location
Vietnam-Ho Chi Minh City-Ho Chi Minh City
Organization
Johnson & Johnson (Vietnam) Co, Ltd (7338)
Job Function
Medical Affairs
Requisition ID
1700195703W
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Confirmed 11 hours ago. Posted 30+ days ago.

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