Join us in our mission to INVENT the future. Let’s be part of our team of dedicated, energetic individuals who are committed to be the most trusted supplier of pharmaceuticals and health products worldwide. Apply now as Clinical Operations Manager to be based in South Korea.

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Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

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Key Responsibilities

식약처 임상시험계획승인 신청/승인 과정을 담당하는 것이 주된 업무 (특히, CMC dossier 준비 및 식약처 제출/승인)

Local process SME (subject matter expert)로서 local activity의 expert역할 수행

임상 업무시 한국 참여 결정부터 첫 임상 개시까지 필요한 start-up 담당(CMC dossier 준비) 및 임상시험 maintenance 단계에서 식약처 관련 업무 담당(CMC amendment 관리)

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Qualifications

Bachelor holder

임상 및/또는 허가개발 업무 5년 이상 경력자 (허가개발 업무 2년 이상 경력 필수)

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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Who we are

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

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What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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지원방법:

https://msd.wd5.myworkdayjobs.com/SearchJobs/job/KOR---Seoul---Seoul-Square/Clinical-Operations-Manager_R68621-1 에 로그인 해서 직접 지원해 주시기 바랍니다.

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