描述

Position Summary

This role is based in Sunway Pinnacle, Malaysia.
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 optimize 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 on the TA

Key Responsibilities:

1. 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. Be responsible for monitoring medical spending and project costs.

2. 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

3. 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.
5% 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

4. 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

5. 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 prioritize 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

资格

Medical or science background (pharmacy, life-science/biotechnology)
PhD or Medical Doctor qualifications are preferred.
3-5 years experience in pharmaceutical Medical Affairs is preferred
Experience in professionals working environment in the pharmaceutical or related industries preferred.
Understanding of local regulatory policy and industry’s code of practice related to drug registration, pharmaceutical promotion and clinical study
Interpersonal and communication skills to effectively interact with a broad range of external and internal personnel.
Awareness of, and adherence to, Johnson & Johnson Credo values and International Health Care Business Integrity Guide