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.
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Post Approval Studies Manager - Mnc Pharma, Taiwan
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Post Approval Studies Manager - Mnc Pharma, Taiwan
Taiwan, 台北, 台北市,
發表 October 1, 2024
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聯繫雇主
雇主信息
Welcome to the Michael Page global company profile.
Michael Page has nearly four decades of expertise in professional services recruitment. We were established in London in 1976, and over this period we've grown organically to become one of the best-known and most respected consultancies, with an office network spanning six continents.
While size has its advantages, it doesn't define us - the nature of our organic growth means that each new office is integrated into the region that it serves. It also means that as an employer looking to hire, or as a candidate aiming to grow your career you have the best of both worlds; a team that understands the market and geography you operate in, plus the resources and expertise of an international network at your disposal.
Our teams are broken down to focus on industry, assignment type, salary level and location, so your hiring requirements or job search will all be handled by a specialist who knows your sector inside-out. We are confident that our expertise can add value to your recruitment or job search process – get in touch to find out more.