美商默沙東藥廠股份有限公司台灣分公司

The role is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.Actively develops and expands the territory for clinical research, finding and developing new sites.Participates in internal meetings and workstreams as SME for monitoring processes and systems. The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems. Responsibilities • Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gains an in-depth understanding of the study protocol and related procedures. • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. • Participates & provides inputs on site selection and validation activities. • Performs remote and on-site monitoring & oversight activities using various tools to ensure: o Data generated at site are complete, accurate and unbiased. o Subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. • Communicates with Investigators and site staff on issues related to protocol conduct,recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed. • Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required. • Supports and/or leads audit/inspection activities as needed. • Performs co-monitoring visits where appropriate. • Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities. Experience Requirements • Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

Summary of Position Development and execution of comprehensive marketing strategies to promote the company’s products and services while providing essential technical support to customers and the sales team. Driving the growth and success of the business through a blend of strategic marketing initiatives and technical expertise. Roles and Responsibilities Product Promotion & Market Insight Develop effective marketing and sales strategies based on market data and emerging trends with excellent analytics and market research skills. Engage with customers, distributors, and motivating team members to achieve business goals. Ensure effective collaboration between departments (e.g., marketing, sales, customer service, and production) for the strategies to be implemented smoothly. Collaborate with swine business unit team for the assigned projects where applicable. Competitors and market intelligence collection and reporting to establish the swine business and marketing plan. Assist with new products launch, including conducting field trial and establish trial protocol, create technical brochure. Technical Support and Training Offer technical assistance to customers, ensuring they understand the product applications and benefits. Products training for colleagues and distributors. Qualifications & Skills Familiarity with pharmaceuticals, swine immunology, vaccinology and other animal health products is particularly important. Major in veterinarian medicine or animal science is preferred. At least 5 years’ experience as technical service/marketing, or technical sales in swine industry. Veterinary license with professional in swine is considerable. Fluent in Mandarin and Taiwanese; Good reading and written communication capability in English. A driver’s license is a must-have. Is willing to travel frequently and work in the field independently. Rich experiences of relevant marketing in the field, and solid understanding in the latest trends, products, and technologies in the swine industry. Required Capabilities Analytical Skills Strong verbal and written communication skills Cross-functional coordination skills Adaptability Strong persuasiveness and the ability to speak in public

Main responsibilities - Support Medical Affairs team in the execution of medical programs and initiatives. - Assist in the review and analysis of medical literature, research findings, and clinical data. - Help ensure compliance with regulatory standards and guidelines in all medical activities. - Collaborate with cross-functional teams, including medical professionals, research and development, marketing, and regulatory affairs, to provide medical insights and support. - Prepare and deliver presentations on medical topics to internal stakeholders and external partners. - Assist in the development and review of scientific materials such as medical publications, training materials, and educational resources. - Stay updated with the latest medical developments, guidelines, and industry trends. - Contribute to medical research projects, including data collection, analysis, and reporting. - Assist in the organization and coordination of medical events, conferences, and educational programs. - Perform administrative tasks related to medical affairs, such as documentation, file management, and scheduling meetings. Qualifications: - This is a 1-year internship program and will require at least 2-3 working days per week committed throughout the program. - Currently enrolled in a medical, pharmaceutical, or related program at an accredited university. - Strong interest in medical affairs and a desire to gain practical experience in the field. - Excellent communication skills, both written and verbal. Proficient in researching medical literature and analyzing scientific data. - Ability to work independently and collaboratively in a team environment. Detail-oriented with strong organizational and time management skills. - Proficient in Microsoft Office (Word, Excel, PowerPoint) and other relevant software. - Knowledge of regulatory guidelines and compliance in the medical field is a plus. - Familiarity with medical terminology and the ability to interpret scientific information.