Praca Regulatory affairs Zdalna

 ...We are excited to announce an opportunity for a skilled and experienced Regulatory Affairs professional to join our dynamic and expanding team at Parexel. This role can be either home or office-based in Warsaw. As a Senior Regulatory Affairs Consultant you will... 

 ...Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented Senior Regulatory Affairs Associate to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various... 

If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us at CRA , home-based, Poland (Warsaw/ Lodz/ Bydgoszcz/ Poznan/ Trojmiasto/ Koszalin / Szczecin...

 ...Specialist / Medical Writer, you will serve as a dedicated, embedded resource supporting the development of high quality clinical and regulatory documents. This role plays an important part in advancing clinical research by ensuring the timely preparation, coordination,... 

Clinical Data Reviewer (Oncology) Poland or Canada Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum...

 ...accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market...  ...-specific Risk-Based Monitoring strategies in alignment with regulatory requirements and internal quality standards. Analyze... 

Wymagane umiejętności i doświadczenie Minimum 1–3 lata doświadczenia w pracy w dziale walidacji.  Znajomość kluczowych przepisów i wymagań: GMP EU, FDA oraz GAMP 5.  Znajomość zasad ALCOA+ oraz normy ISO 14644-3.  Swoboda w pracy z dokumentacją techniczną oraz...

 ...degree or health data sciences degree preferred Expert in Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements. Expert in Risk-Based Monitoring Strategies processes and tools preferred. Expert in Integrated Quality Risk... 

 ...qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate... 

Site Contracts Specialist II/ Sr Specialist with German - Sponsor-dedicated Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and...

Clinical Data Manager / Project Data Manager - Sponsor-dedicated, Poland Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization...

Principal Global Feasibility Lead - Sponsor-dedicated, EMEA Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization...

 ...consumer protection, and promotional claims. • Participate in marketing compliance audits and implementation of corrective actions. Regulatory Monitoring • Monitor legislative and regulatory developments in relevant jurisdictions and assess their impact on products and... 

Doświadczenie we wspieraniu co najmniej 1–2 systemów GxP lub systemów krytycznych dla biznesu w branży farmaceutycznej. Doświadczenie w pracy w regulowanym środowisku IT (Pharma GxP). Wiedza z zakresu jakości, zgodności IT (IT Compliance) lub walidacji; doświadczenie...

 ...requirements are met. May contribute to development of training programs, where appropriate. Assures adherence to good ethical and regulatory standards. Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality... 

About ICON ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of...

 ...accordance with data protection and confidentiality standards. Conduct comprehensive legal research and analysis on international regulatory matters. We offer: Industry Leader: Make a meaningful contribution to a globally recognized solution that shapes the future... 

 ...described in the SAP and specifications. May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of... 

Professional Background: Proven track record in Procurement, Third-Party Risk Management (TPRM), Vendor Management, or Corporate Compliance. Risk & Governance Expertise: Direct familiarity with formal corporate onboarding frameworks, including ABC checks, reputational...

 ...Banking & Financial Services Investment, Corporate or Retail Banking Payments, Cards & Lending platforms Risk, Compliance, AML, Regulatory Change Core Banking or Data Transformation Markets & Trading Front / Middle / Back Office transformation Trading platforms & capital... 

Billennium to globalna firma technologiczna z ponad 20-letnim doświadczeniem, zaangażowana w innowacje i wspieranie przedsiębiorstw. Jako pracodawca oferujemy wspierające, nastawione na rozwój środowisko, w którym współpraca i kreatywność to naczelne wartości. Dołącz do...

 ...System processes, procedures and best practices for both technical support teams and clinical teams. Participates in audit and regulatory inspection preparation activities and assist in the development and delivery of CAPA to time and quality, when applicable.... 

Miejsce pracy Poznań / Warszawa / Zdalnie Region Poznań; Warszawa; Zdalnie Opis oferty Jesteśmy nowoczesną kancelarią prawną, która łączy ekspercką wiedzę prawniczą z dogłębnym zrozumieniem biznesu i technologii. Do naszego dynamicznie rozwijającego się Departamentu...

Your skills: Degree in Law Understanding of core legal principles under Ukrainian, EU and US law Strong tech literacy, ability to learn new tools and systems quickly Sharp attention to detail Curiosity, proactive approach, and eagerness to learn English...

Minimum 4 years of professional experience in Data Management, Data Governance, Metadata Management, Data Catalog Administration, or Business Analysis . Experience working with metadata documentation and data cataloging . Basic knowledge of the Atlan Data...

Miejsce pracy Łódź / zdalnie Rodzaj umowy Umowa o pracę Region łódzkie; podlaskie; praca zdalna Opis oferty CERI to miejsce, w którym spotykają się ludzie na wszystkich etapach kariery. Nieustannie uczymy się od siebie nawzajem, doceniamy zaangażowanie...

 ...Phase I-IV clinical trial operations and workflows Expertise pertaining to clinical trial management software Knowledge of applicable clinical research, regulatory and other requirements; i.e., Good Clinical Practice, HIPAA, GDPR, EMA, GAMP5, FDA 21 CFR Part 11... 

Miejsce pracy Kraków / zdalnie Opis oferty Zapraszamy do rozmów o ofercie pracy w Instytucie - organizacji pozarządowej typu think-tank, która łączy środowiska pracodawców, prawników, naukowców, pracowników i urzędników tworząc ważne w Europie forum wymiany wiedzy...

Min. 5 lat doświadczenia w bezpieczeństwie informacji, zarządzaniu ryzykiem, odporności operacyjnej, audycie lub governance Doświadczenie w zarządzaniu wieloma równoległymi działaniami i współpracy z senior interesariuszami Dobra znajomość techniczna infrastruktury...

We are seeking a detail-oriented and reliable Data Associate to support our data management processes. The ideal candidate will be responsible for collecting, organizing, analyzing, and maintaining accurate data to support business operations and decision-making. Key...