As the Therapeutic Area Lead you will, 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 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.
**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
- 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)
- 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 to fulfil medical education and knowledge gaps as defined in medical affairs plan and take ownership and proactive approach in working with faculty for ensure high quality of scientific content. - Take ownership in designing and leading Medical Advisory Boards.
- 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 to gather information and insights on therapy area (inc. Competitor landscape) and their medical and scientific needs, to exchange disease area knowledge and opinions to understand the emerging opinions, to increase the customers understanding of Janssen products and processes, and to 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).
- Ensure External and Internal Compliance - To ensure compliance through understanding, implementation, and adherence to HCBI, global/regional/local SOPs, GSQA, local regulatory policy and industry codes of practice
- Medical training - Provide Medical and Scientific training for internal stakeholders and external customers if required, including Sales and Marketing Colleagues and 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 team and input medical insights in brand team strategies. - Engage with internal stakeholders on topics of mutual interest in to encourage optimal use and/or understanding of Janssen products.
**Qualifications**:
- Relevant life-science background (Medicine, pharmacy, life-science/biotechnology)
- Medical Doctor qualification is preferred.
- 3-5 years of 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.