Job Description

JOB DESCTIPTION COMPANY Lotus Pharmaceutical is the largest pharmaceutical company in Taiwan by annual net sales and continues to grow rapidly with a strong pipeline and portfolio including high-barrier oncology, complex generics. Lotus is an integrated pharma company with its own development and manufacturing sites located in Taiwan. Over the past years the Lotus leadership team has transformed the company from a local pharmaceutical company in Taiwan to a highly diversified international pharma company driven by exports to US, Europe, LATAM, MENA. SUMMARY OF POSITION Coordinate, plan and execute clinical studies in relationship with the registration of the in-licensed medicinal products. Align to a regulatory submission strategy in the clinical development part of the projects. ORGANIZATION STRUCTURE Reports to: VP - Clinical development Relationships (Internal): Manager & all other relevant colleagues depending on the tasks performed. Relationships (External): Communicates with different professional, governmental and non-governmental organizations and their representatives and contacts with different institutions, organizations and agencies depending on the tasks performed. RESPONSIBILITIES The role coordinates all aspects of medical support in clinical development of the products: Collect information within internal stakeholders of R&D and Regulatory Affairs regarding the clinical study requirements and supports MAAs, other applicable regulatory authority applications and approvals for the local clinical trials conduction and medicinal products. Designing appropriate clinical study feasibility according to the study molecule nature, applicable regulatory requirements, and guidelines assigned by the management. Clinical/ Medical evaluation of products for EU and APAC region and assess their opportunity by closely working with Formulation, Regulatory, Intellectual Property (IP) and Business teams. New product ideation to business, portfolio, and R& D team in development of the pipeline molecules Propose clinical development strategies for complex generics i.e. liposomes, transdermal preparations, depot injections, inhalational products, and nasal sprays. Develop clinical strategy for both new and differentiated products including 505 b2 applications. Suggest innovative approaches including clinical waivers to enable clinic-regulatory discussions for conventional generic products. Prepare and provide clinical inputs to Briefing Books and Controlled Correspondence documents submitted to the Agencies (US-FDA, EMA) for Scientific Advice. Provide resolutions for regulatory deficiencies and queries from cross-functional teams. Provide key medical opinions in Selection of the products. Preparation and review of clinical study synopses and protocols. Provide clinical support for IP litigations. Medical due diligence of in-licensing dossiers. To provide medical monitor support including eligibility evaluation for patient based clinical studies, review of AE/ SAE\'s Identification of Contract Research Organizations (CROs), obtaining the feasibility and quotes (budgets proposals), summarizes & presents to Management team (as applicable). Reviews of essential study documents such as study protocols, clinical reports and any other clinical documents requested for the registration purposes. Manages the bioequivalence/pharmacokinetic, patient-based bioequivalence and Nonclinical, In-vitro studies etc. for which he/she has been assigned by the VP-Clinical throughout study conduct. Precise scientific assessment and efficient strategic planning for the clinical development of generic drug product for EU, US and APAC and other intended markets that will help to portfolio/management to get insight on criticality, cost, and development timelines on clinical front. Additional responsibilities can be assigned by the Management as and when required. Travelling might be required as and when assigned by the management. QUALIFICATION & EXPERIENCE M.B.BS/MD with minimum 2-3 years\' experience in clinical research or Clinical Pharmacologist with 8-10 years\' experience in pharmaceutical/CRO industry Experience of handling molecules for USA, Europe, APAC markets are preferred. General knowledge of Clinical Development process; strong knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and other related documents Experienced in interacting with the Regulatory agencies and supporting agency\'s inspections from a clinical perspective. CORE COMPETENCIES Business Focus Drive for Results Building Team Spirit Customer Service Embracing Change Quality

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