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Post Approval Studies Manager - Mnc Pharma, Taiwan

發表 2024-10-01
過期 2024-11-01
ID #2371293487
Free
Post Approval Studies Manager - Mnc Pharma, Taiwan
Taiwan, 台北, 台北市,
發表 October 1, 2024

描述

About Our Client Our client is a global life sciences company, dedicated to making a positive impact on people's lives and the planet.

With a rich history spanning over several decades, our client has established itself as a leading force in the fields of healthcare and agriculture.

Through innovative solutions and a strong commitment to sustainability, our client continues to shape the future of medicine, nutrition, and high-quality agricultural products.

Job Description* Oversee the implementation and management of post-approval studies, encompassing Non-Interventional Study (NIS) and Investigator-Initiated Research (IIR) initiatives, spanning various therapeutic areas.

Ensure stringent adherence to medical governance, regulatory compliance, and high-quality data delivery.* Facilitate the facilitation of new drug applications by orchestrating the country assessment report, a pivotal regulatory prerequisite for registration studies.* Spearhead site management activities and protocols for NIS, ensuring the optimal performance, adherence to quality standards, efficiency, and efficacy of the trial sites.* Supervise the internal Site Management budget, with a focus on overseeing external clinical grants on an annual basis.

Such grants encompass all costs associated with relevant NIS and IIR clinical trials, including investigator payments and study supplies.* Guarantee the provision of adequate and efficient resources for each clinical trial, aligning resources with trial needs and objectives.* Foster close collaboration with medical advisors and Medical Science Liaisons (MSLs) within pertinent Therapeutic Areas (TAs) to ensure the success of ongoing studies.* Manage contracts, vendor relationships, budgetary allocations, and administrative coordination of patient support programs, in consultation with the responsible Medical Advisor for the program.* Assume responsibility for the management of the post-approval study team, ensuring their competency training and professional development.* Ensure the streamlined execution of NIS & IIR, adhering to internal benchmarks and meeting local legal and regulatory requirements.* Foster the development of a robust clinical investigator network in the region to support efficient clinical trial execution and contribute to the overall business strategy.

The Successful Applicant* Possession of a Bachelor's degree (or equivalent) in a science or healthcare-related field.* Minimum of 5 years' hands-on experience in clinical trials or clinical operations, with a solid grasp of ICH-GCP guidelines and pertinent legal, compliance, and regulatory mandates.* Demonstrated experience in leading teams, showcasing strong leadership, motivational, and collaborative skills.* Proficiency in administrative, financial, and technical competencies, along with excellent verbal and written communication abilities in English, both internally and externally.* Ability to think strategically, with a keen eye for the bigger picture and a focus on fulfilling broader business objectives.* Exhibit innovation and creative problem-solving capabilities, while maintaining a results-driven approach.* Possess a strong business acumen and demonstrate genuine interest in business dynamics and operations.

職位詳情

工作類型: 全職
合同類型: 永恆的
薪酬類型: 每月
職業: Post approval studies manager - mnc pharma

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