
Site Activation and Regulatory Lead
2 days ago
Regulatory and Start Up Specialist
Job SummaryThis role involves performing tasks at a country level associated with Site Activation (SA) activities, ensuring adherence to applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual guidelines.
Key Functions- 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, ensuring adherence to 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, distributing 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, ensuring monitoring measures are in place and implementing contingency plans as needed.
- 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.
-
Solna Municipality, Sweden TN Sweden Full timeJob OverviewAs a key member of our team, you will be responsible for performing 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 guidelines. This role may also involve maintenance...
-
Site Leadership Manager
2 days ago
Haninge Municipality, Sweden TN Sweden Full timeJob DescriptionThe Site Manager will be responsible for managing operations, ensuring safety and regulatory compliance, and leading, coaching, and developing our team. Key responsibilities include:Delivering on ISC targets for HSE, VMC, and FMC productivity, quality, and growthLeading the implementation of the ISC strategy and Nouryon Leading Performance...
-
Start Up and Compliance Manager
2 days ago
Solna Municipality, Sweden TN Sweden Full timeJob DescriptionWe are seeking an experienced professional to join our team as a Regulatory and Start Up Specialist. The successful candidate will be responsible for performing tasks at a country level associated with Site Activation (SA) activities, ensuring adherence to applicable local and/or international regulations, standard operating procedures (SOPs),...
-
Clinical Research and Operations Specialist
2 days ago
Solna Municipality, Sweden TN Sweden Full timeJob OverviewThis role is part of our global organization and involves performing tasks at a country level associated with Site Activation (SA) activities, ensuring adherence to applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual guidelines.ResponsibilitiesServe as Single Point of...
-
Site Operations Director
2 days ago
Haninge Municipality, Sweden Nouryon Full timeAt Nouryon, our global team of professionals takes positive action every day to reach higher collectively and individually. We create innovative and sustainable solutions for our customers to answer society's needs – today and in the future.About the JobYou will be responsible for delivering on our strategy and achieving agreed targets, all while driving...
-
Regulatory Affairs Expert
2 days ago
Solna Municipality, Sweden PharmaRelations ApS Full timePharmaRelations ApS seeks an experienced Medical Information Consultant to join their team.Key Qualifications:Excellent knowledge of regulatory affairs and compliance within the life sciences sector.Strong understanding of medical information databases and tools.Responsibilities:Develop and implement innovative first-line medical information solutions.Lead...
-
R-45521 Site Lead
1 week ago
Solna, Sweden Siemens Gamesa Renewable Energy AB Full timeSiemens Gamesa has a vision for renewable energy: we believe in the power of nature and technology. Help us to be ready to face the energy challenges of tomorrow and make a green footprint – join the team in creating a better future for us on our planet. We focus on hiring the best people, wherever they may be in the world. We pride ourselves on the...
-
Account Lead
2 days ago
Solna Municipality, Sweden Johnson & Johnson Full timeAbout the RoleThe CAR-T Cell Therapy Account Lead (CTAL) drives the Nordic treatment site solution strategy within the local Operating Company business objectives/strategies. This position works in the Nordic Business Unit Cell Therapy, reporting to the Nordic Business Unit Lead.In this role, the CTAL supports the solution strategy development and tactical...
-
Site Operations Manager
2 days ago
Lysekil Municipality, Sweden TN Sweden Full timeAs a key member of our team at TN Sweden, the Site Operations Manager will oversee various administrative functions on our construction project sites. This individual will serve as the primary liaison between the site and our EPCM contractor, fostering effective communication and collaboration to ensure seamless project execution.Responsibilities:Site...
-
Facilities and Administration Lead
2 days ago
Lysekil Municipality, Sweden TN Sweden Full timeThe Facilities and Administration Lead at TN Sweden oversees the maintenance and upkeep of our construction project sites, ensuring a safe, healthy, and productive work environment. This role requires a skilled professional who can prioritize tasks, manage multiple projects, and collaborate effectively with diverse stakeholders.Key...
-
Operations Excellence Lead
2 days ago
Haninge Municipality, Sweden Nouryon Full timeNouryon is a leading company that creates innovative and sustainable solutions for its customers. We are seeking an experienced professional to lead our operations and drive continuous improvement initiatives.About the JobThe ideal candidate will be responsible for delivering on our strategy and achieving agreed targets, all while driving continuous...
-
Power Systems Specialist Lead
2 days ago
Solna Municipality, Sweden Hitachi Vantara Corporation Full timeJob DescriptionWe are seeking a Power Systems Specialist Lead to join our Sustainability & Technology Transformation team. As a key member of this team, you will develop advisory projects for the energy sector, helping them address sustainability, regulatory, economic, and technology challenges.In this role, you will work in an environment of international...
-
EHS Excellence Lead
2 days ago
Järfälla Municipality, Sweden Bravura Sverige AB Full timeAbout the RoleElevate your career in Environment, Health, and Safety with our company as an EHS Excellence Lead. We are seeking a motivated and skilled leader to drive excellence across our operations.As the EHS Lead, you will ensure compliance with regulatory requirements while fostering a culture of safety and sustainability. You will lead ISO 14001:2015...
-
Research Coordinator
2 days ago
Solna Municipality, Sweden TN Sweden Full timeCompany OverviewTN Sweden is a leading provider of clinical research services, dedicated to delivering high-quality results and exceptional customer service.Job DescriptionThe Clinical Trial Assistant will work closely with the Clinical Research Associates and Regulatory and Start-Up teams to ensure the timely completion and accuracy of Trial Master File...
-
Lead Medical Strategist, Cardiovascular
2 days ago
Solna Municipality, Sweden TN Sweden Full timeAbout This OpportunityWe are looking for a highly skilled Lead Medical Strategist, Cardiovascular to join our team as a Medical Strategy Lead to help us expand our Cardiovascular portfolio and advance this dynamic and rapidly expanding area of clinical development.The ideal candidate will have robust and current knowledge of scientific, clinical, regulatory,...
-
CAR-T Cell Therapy Operations Specialist
2 days ago
Solna Municipality, Sweden Johnson & Johnson Full timeNordic Cell Therapy Account Lead OverviewThis is an exciting opportunity to join our team as a CAR-T Cell Therapy Account Lead. In this role, you will be responsible for driving the Nordic treatment site solution strategy within the local Operating Company business objectives. You will work closely with cross-functional teams to develop solution strategy and...
-
Cell Therapy Business Development Manager
2 days ago
Solna Municipality, Sweden Johnson & Johnson Full timeAbout Johnson & JohnsonJohnson & Johnson is a multinational healthcare company that focuses on developing innovative medical solutions. As a leader in the industry, we strive to deliver high-quality products and services that improve people's lives.Nordic Cell Therapy Account Lead Job DescriptionThe CAR-T Cell Therapy Account Lead plays a crucial role in...
-
Legal and Regulatory Affairs Manager
2 days ago
Solna Municipality, Sweden F. Hoffmann-La Roche Gruppe Full timeKey ResponsibilitiesDevelop and implement comprehensive legal and compliance strategies, aligning with business priorities and goals.Maintain Roche's license to operate by ensuring compliance with applicable laws, regulations, principles, and standards, including antitrust, data privacy, public procurement, anti-bribery regulation, employment, and product...
-
Refinery Site Safety Expert
2 days ago
Lysekil Municipality, Sweden TN Sweden Full timeResponsibilitiesThe HSE Supervisor will oversee the entire construction process, from planning to execution.You will coordinate and supervise all construction activities on-site, including both brownfield and greenfield areas.Your key responsibilities will include allocating resources efficiently, ensuring safety standards are met, and maintaining effective...
-
Refinery Site Coordinator
2 days ago
Lysekil Municipality, Sweden TN Sweden Full timeThe ideal candidate for this Refinery Site Coordinator role will have extensive experience in construction project management and a proven track record of delivering results. You will be responsible for overseeing the execution of construction projects at our refinery site in Sweden.Key Skills:Extensive experience in construction project management.Strong...