![IQVIA](https://media.trabajo.org/img/noimg.jpg)
Regulatory and Start Up Specialist 2
2 weeks ago
Job Overview
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. At least 3 years' experience with submissions. Fluent in both Swedish and English.
Essential Functions
Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members. Prepare site regulatory documents, reviewing for completeness and accuracy. Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. Review and provide feedback to management on site performance metrics. Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed. Inform team members of completion of regulatory and contractual documents for individual sites. Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines. Provide local expertise to SAMs and project team during initial and on-going project timeline planning. Perform quality control of documents provided by sites. May have direct contact with sponsors on specific initiatives.Qualifications
Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience ; or equivalent combination of education, training and experience. 1 year experience in a leadership capacity. Equivalent combination of education, training and experience. In-depth knowledge of clinical systems, procedures, and corporate standards. Ability to manage multiple projects. Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines. Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards. Understanding of regulated clinical trial environment and knowledge of drug development process. Ability to establish and maintain effective working relationships with coworkers, managers and clients.IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at
-
Associate Director, Clinical Regulatory Writing
3 weeks ago
Gothenburg, Västra Götaland, Sweden AstraZeneca Full timeAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...
-
Associate Director, Clinical Regulatory Writing
1 month ago
Gothenburg, Sweden AstraZeneca Full timeAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...
-
SEO Specialist, Vikariat
3 weeks ago
Gothenburg, Västra Götaland, Sweden Jollyroom Full timeJoin the journey with JollyroomJollyroom, the e-commerce platform that started in 2010 and now dominates the Nordic market as the largest online store for children's products. Our goal is to offer not just products, but a complete lifestyle experience for parents in Europe. With over 2 million satisfied customers and a range that includes products for...
-
SEO Specialist, Vikariat
3 weeks ago
Gothenburg, Västra Götaland, Sweden Jollyroom Full timeHop on board with Jollyroom - the e-commerce company that kicked off in 2010 and now dominates the Nordic market as the largest online store for children's products. We aim to offer not just products, but a complete lifestyle experience for parents in Europe. With over 2 million happy customers and a range that includes products for expectant mothers,...
-
Software Engineer Level 2
2 weeks ago
Gothenburg, Sweden Adiga Full timeJob DescriptionJob Title: Monitoring Software Developer Location: Gothenburg and Lund, Sweden Start Date: 2024-06-24 Description: The main Swedish automotive OEM is looking for a Software Developer to join the Connectivity and Cloud Platform team. In this role, you will work on platforms such as Connected Car Cloud Platform, Telematics Platform, and Mobile...
-
Software Engineer Level 2
2 weeks ago
Gothenburg, Sweden Adiga Full timeJob Title: Monitoring Software Developer Location: Gothenburg and Lund, Sweden Start Date: 2024-06-24 Description: The main Swedish automotive OEM is looking for a Software Developer to join the Connectivity and Cloud Platform team. In this role, you will work on platforms such as Connected Car Cloud Platform, Telematics Platform, and Mobile Network Access...
-
CAD Specialist
3 weeks ago
Gothenburg, Västra Götaland, Sweden Essity Full timeWe are Tork – the #1 brand of professional hygiene solutions in the world. We are a billion-dollar B2B brand that's part of a company called Essity, a leading global health and hygiene company with $12B net sales in over 150 countries and more than 36,000 employees globally. About the role We are looking for a CAD Specialist within Essity ́s global unit...
-
CAD Specialist
3 weeks ago
Gothenburg, Västra Götaland, Sweden Essity AB Full timeEssity B SEK) on 11-Jun :14 We are Tork – the #1 brand of professional hygiene solutions in the world. We are a billion-dollar B2B brand that's part of a company called Essity, a leading global health and hygiene company with $12B net sales in over 150 countries and more than 36,000 employees globally. About the role We are looking for a CAD Specialist...
-
Marketing Compliance Senior Specialist
4 weeks ago
Gothenburg, Sweden PharmaLex Full timeDo you want to develop your skills working side by side with top professionals in the pharmaceutical industry? Marketing Compliance Senior Specialist to join our Nordic Promotional Materials & Compliance (PMC) team. Here are some examples of the many interesting tasks your work day may consist of: You will review marketing materials for our...
-
Marketing Compliance Senior Specialist
3 weeks ago
Gothenburg, Västra Götaland, Sweden PharmaLex Full timeDo you want to develop your skills working side by side with top professionals in the pharmaceutical industry? Marketing Compliance Senior Specialist to join our Nordic Promotional Materials & Compliance (PMC) team. Here are some examples of the many interesting tasks your work day may consist of: You will review marketing materials for our clients...
-
Senior Process Technology Specialist
3 weeks ago
Gothenburg, Västra Götaland, Sweden A-hub Full timeWe are now looking for a Process Technology Specialists to strengthen Perstorp's Global Technology & Investment organization (GTI).The Process Technology Specialists are Perstorp's experts within the internally developed technologies. They are typically acting in the same way as external technology licensors in investment projects to safeguard/guarantee that...
-
Regulatory Analyst, CTC E-Invoicing Compliance
1 month ago
Gothenburg, Sweden Pagero Group Full timeEnsuring global compliance with e-invoicing and CTC mandates is a significant challenge for multinational corporations. Regulations surrounding indirect tax and use of tax technologies have been increasing with little to no uniformity among regulators. Since requirements in these areas are complex, fragmented, and constantly changing, we are searching...
-
Gothenburg, Sweden Pagero Group Full timeEnsuring global compliance with e-invoicing and CTC mandates is a significant challenge for multinational corporations. Regulations surrounding indirect tax and use of tax technologies have been increasing with little to no uniformity among regulators. Since requirements in these areas are complex, fragmented, and constantly changing, we are searching...
-
Support Specialist PIM
3 weeks ago
Gothenburg, Västra Götaland, Sweden Essity AB Full timeEssity B SEK) on 02-Jun :29 Do you have experience from product information management (PIM) and/or end user support, and want to be part of our exciting digital journey? In this position at Essity, you will get the opportunity to be part of a global team and support local users of our PIM system, in order to provide high quality product information in all...
-
Payroll & Benefits Specialist
3 weeks ago
Gothenburg, Västra Götaland, Sweden Molnlycke Health Care Full timePress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Create Alert Advance performance, transform lives, and grow your career in an international environment. If you have a passion for Payroll and Benefits along with supporting managers and colleagues, our People Services Specialist role could be your next...
-
Support Specialist PIM
3 weeks ago
Gothenburg, Västra Götaland, Sweden Essity Full timeSupport Specialist PIM (Product Information Management) page is loaded Support Specialist PIM (Product Information Management) Apply remote type Hybrid locations Gothenburg time type Full time posted on Posted 8 Days Ago job requisition id Essity243785 Do you have experience from product information management (PIM) and/or end user support, and want to be...
-
Application Specialist
3 weeks ago
Gothenburg, Västra Götaland, Sweden Business English Academy Full timeApplication Specialist - MS Business Central/LS RetailDo you want to join the LS Central team in the Onboard Sales & Service Digital department, as our new Application Specialist? The team is responsible for the development of digital products related to tills, ordering, replenishment etc. onboard Stena Line's fleet. We are delivering innovative commercial...
-
IT Infrastructure Specialist
3 weeks ago
Gothenburg, Västra Götaland, Sweden ASSA ABLOY Full timeIT Infrastructure SpecialistAre you ready to bring your innovative perspective and creative skills to ASSA ABLOY Entrance Systems? Join our team in Västra Frölunda, Sweden, and enjoy a collaborative culture that empowers you to build a career you can be proud of.What you would do as our IT Infrastructure SpecialistThe IT infrastructure specialist is...
-
It Infrastructure Specialist
3 weeks ago
Gothenburg, Västra Götaland, Sweden ASSA ABLOY AB Full timeIT Infrastructure SpecialistAre you ready to bring your innovative perspective and creative skills to ASSA ABLOY Entrance Systems? Join our team in Västra Frölunda, Sweden, and enjoy a collaborative culture that empowers you to build a career you can be proud of.What you would do as our IT Infrastructure SpecialistThe IT infrastructure specialist is...
-
Customer Education Specialist
3 weeks ago
Gothenburg, Västra Götaland, Sweden Meet a Groups kund Full timeJobbify är en jobbplattform för vassa kandidater.För kunds räkning har vi publicerat denna annons, vill du komma i kontakt med den slutgiltiga arbetsgivaren kan du klicka dig vidare till annonsen:Kognic is on a mission to make everything that moves autonomous. We help AI product teams better understand their data by providing the best dataset management...