Milton Hershey School (MHS) is one of the world's best private schools, where students from lower income families who are looking for greater opportunity are able to explore their individual interests to the fullest. Thanks to the generosity of Milton and Catherine Hershey, the school is fully endowed with the resources to ensure every child and staff member has what they

Regulatory Affairs Consultant must have an understanding of the organization's consulting models and methodologies, as well as good knowledge of what services PC provides. The Consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. This key role in the organization ensures the timely performance of wo

We are recruiting for experienced Regulatory Affairs Professionals on various levels. In this role, you will focus on clinical trial submissions. We are looking for someone who is experienced in CTA, EU CTR knowledge and experience would be a strong plus. The role can be based in our office in Madrid or remote. Key Deliverables in the role Manage the local submissions (as

Deliver/Lead specific Systematic Literature Review project steps e.g. screening, extraction, protocol design, quantitative feasibility. Understands project specific requirements to customize deliverables per specifics and apply innovative evidence presentation strategies. Develops project deliverables as required in a typical Systematic Literature Review project e.g., sys

Deliver/Lead specific Systematic Literature Review project steps e.g. screening, extraction, protocol design, quantitative feasibility. Understands project specific requirements to customize deliverables per specifics and apply innovative evidence presentation strategies. Develops project deliverables as required in a typical Systematic Literature Review project e.g., sys

PMDA MHLW NDA 1. NDA US EU PMDA PMDAPMDA NDA CTDNDA ODD 2. CRO 10 PMDA JNDACTD PMDA Microsoft Excel WordPower Point

Local submission of CTA according to the EU directive until the end of the transition period in Belgium, France, Luxembourg and Monaco, then submission according to EU CTR Local submission of MAP and NIS Education Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree Preferred Language skills Must be fluent in French and Englishcommunicat

Senior Regulatory Affairs Associate must understand the organization's consulting models and methodologies, as well having as good knowledge of what services PC provides. The Senior Regulatory Affairs Associate must have good technical skills and may be developing specialist knowledge of a particular subject and/ or market. This key role in the organization ensures the ti

We are looking for a Senior Regulator y Affairs Associate to join our growing team in Romania. This role can be either home or office based in Bucharest. As a Senior Regulatory Affairs Associate you will come with a few years of Regulatory Affairs experience gained in the industry. You will bring experience in Clinical Trail Applications (CTA) from various European locati

1. Should have experience in eCTD, NeeS and paper formats. 2. Working experience in all major emerging countries (EU, GCC, US, ASEAN etc.) 3. Compilation, publishing, and technical quality control of Regulatory submissions including technical troubleshooting to ensure issues with submissions are resolved and deadlines met. 4.Should have experience in handling submission g

Duties WHAT IS THE APPEALS DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Independent Office of Appeals Specialized Exam Programs & Referrals/Area 10/Team 2 The following are the duties of this position at the full working level. Conducts Appeals conferences for the settlement of the largest and most

& Essential Functions include Data Integration and Analysis. Supporting various data integration efforts by performing data entry, editing, and/or validation tasks. Maintaining integrity related databases and tracking tools. Providing data maintenance support as directed by, and with oversight from, Integrity department staff. Performing basic data analytics and visualizat

Participates in and identifies specific tests while executing test scenarios for unit, process, function, system integration, regression and acceptance testing. Defines criteria for testing, analyzes results of testing sessions and presents testing results to project stakeholders. Reviews applicable requirements in order to develop complex test cases, scenarios and script

include Works individually and as a team to engage with potential and active program participants Assists during direct service delivery to facilitate participant flow and throughput Assists program participants both during direct service delivery and telephonically in identifying personal recovery goals, assisting in setting objectives for each goal, and determining inter

Team Lead for 4 Category Analysts and External Partners Drive Alignment and Prioritization with Global and Regional Raw Material Directors and Leadership Team(s) Enhance short and long term team vision Support, Enable, and Parter with assigned Category Managers Operate with knowledge of purchasing policies, processes, and guidelines Develop solutions to complex and time s