SC Medical Director
2 settimane fa
Overview
WE PUSH THE BOUNDARIES OF MEDICINE.
LEAPING FORWARD TO MAKE PEOPLE SMILE
At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We are an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.
Responsibilities
Ensure optimal medical and scientific support across the Cluster both externally - to the medical community - and internally. A strategic and operational role, responsible for providing optimal patient care without ever crossing any medical/ ethical/ compliance line for commercial gain.
Key Responsibilities:
Develop the medical strategy through the Medical Plan, aligned with the company strategy, being able to analyse not only the own reality, but also the environment, competitors and stakeholders Coordinate the cluster oncology team with an operational day-to-day oversight of the SRMs Build and maintain a professional network with relevant members of medical/scientific community, pharmaceutical organisations, patient associations, insurance companies and other applicable institutions. Obtain and maintain in-depth knowledge on all aspects of the relevant KKI product(s). Obtain and maintain in-depth medical, scientific, clinical knowledge of the relevant therapeutic area by following training classes, studying literature, attending scientific sessions at congresses and, importantly, exchanging information with knowledgeable and/or experienced HCPs in the field. Obtain and maintain in-depth knowledge of guidelines, codes of practice, relevant local law, internal policies and SOPs related to clinical research, promotional materials and activities, as well as informative/educational programs and materials. Communicate balanced, substantiated and relevant scientific information for internal and external stakeholders. Respond professionally to clinical information and data requests in relation to disease or treatment specific questions or off-license queries. Final sign off of marketing materials. Creation and/or review of medical materials, e.g., literature reviews, medical letters, slide kits etc. Input into cross-functional deliverables such as Regulatory Affairs (SmPC updates, DHCP letters, letters to competent authorities) or Market Access (dossiers, tenders etc.). Execute Risk Management Plan if applicable. Facilitate publication of relevant local scientific and/or patient management data on KKI products Gain and maintain good understanding of the quality system within the company, including PV, product complaint/recall handling and GDP. Liaise with local patient organisations to find out about patients’ needs and required patient support. Give input into EMEA issues and projects. Ensure appropriate response to unsolicited scientific requests by HCP`s for licensed products/brands (on and off label), and for products in development in different clinical trials phases, by providing accurate scientific data in compliance with company policies, and country specific legal and ethical requirements. Develop KOL engagement plans and associated patient value insights and outcomes. Actively develop agendas for, and participate in, advisory board meetings and clinical investigator meetings. Facilitate expert lectures and external expert speakers with national, regional, or global recognition.
Qualifications
Relevant medical/pharmacy/nursing/bioscience background (higher degree preferred) Knowledge of Regulatory Affairs, legal and compliance regulations and authorities nationally Extensive experience in Medical Affairs Department In-depth knowledge of local, regional and national healthcare systems and processes for allocation and delivery of care Track record of successful working with cross functional teams locally and internationallyHigh proficiency in English Well-developed interpersonal and communication skills with the ability to understand healthcare professional prospective and forge long term relations of mutual value Acts as role model for others in line with Kyowa Kirin culture and values Pharmaceutical Industry Acumen Research Methodology and Clinical Biostatistics Local and International Pharmaceutical Legislation, Sanitary Legislation. Good Clinical Practices and Pharmacovigilance Therapeutic areas and company products IT Tools and Database Medical Management Systems
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