Lead regulatory submission process, to contribute expansion of business. Maintain of product registration and related lincenses like MAH or manufacturing site through change control process. Requires basic knowledge of IVD/MD regulation and QMS. Will also cover regulations about
■ 職務内容 / Job Description Medical Communication Scientist (MCS) is a role name in AZKK and is generally known as medical writer. MCS is responsible for the authoring of clinical-regulatory documents and submission packages that communicate the evidence
Title: Regulatory Affairs Manager Company: IPSEN K.K. Job Description: Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health
JOB DESCRIPTION Job Title: Associate Director, Regulatory Affairs Japan Department / Cost Center: Regulatory – 210 Reports to (Job Title): Head of APAC Regulatory Affairs Job Code: Location: Tokyo Date Prepared: April 2024 Full-Time Part-Time Regular Temporary Exempt Non-Exempt
Work Schedule Other Environmental Conditions Office Job Description When you’re part of the team, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe.
Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive
This is what you will do: Associate Director, Regulatory Affairs is responsible for overall pharmaceutical affairs associated with obtaining pharmaceutical product approval. The duties include complying with Japan pharmaceutical affairs act, developing good relations with the regulatory authority,
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring
Title: Medical Advisor / Medical Scientific Liaison FOP Company: IPSEN K.K. Job Description: As part of the Medical Affairs department, the MA/MSL is a hybrid, field-based scientific expert to external and internal stakeholders delivering non-promotional information
Job Description: At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. Responsible Growth is how we run our company and how we
Job Description Summary -Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change
This is what you will do: The Senior Manager, Project Management is accountable for the generation and maintenance of program timeline for Japan local portion including Advisory Board meeting, internal governance endorsements, PMDA consultation, J-CTN, clinical
Medical Advisors provide medical and scientific expertise and guidance to investigators and CSU (Clinical Study Unit) staff performing clinical trials within a CSU cluster to ensure patient safety and scientific integrity of the protocol which ensures
Job Description Summary Defines and drives scientifically sound and business driven project strategy. Reviews, manages, proactively challenges, and controls status of projects operations of the programs and budgets; manages schedules and may prepares status reports. Guides
Role Purpose:This position will drive the execution of Market Access strategies specific to the Edwards BU portfolio of innovative therapeutic solutions for structural heart disease and/or advanced critical care technologies in Japan. The successful candidate will
Career Category Clinical Job Description Responsible for Ensuring that all statistical aspects of documentation pertaining to clinical programs and non-study activities meet required standards and are statistically correct. Influencing study design and analysis, and defending statistical
Job Description SummaryJob Overview With global impact and oversight, manage a department of Biostatistics and Statistical Programming staff ensuring that target productivity (project allocations, utilization, and output) levels are met. May fulfill the role of site
Job Description The Senior Manager / Manager of Clinical Pharmacology in Clinical Pharmacology & Pharmacometrics (CPP) serves as the clinical pharmacology country lead on program, clinical pharmacology, and clinical study teams, providing strategic leadership and expertise