55 job matcher din søgning
Orphazyme A/S, Copenhagen
Orphazyme is a progressive and innovative Danish biopharmaceutical company based in Copenhagen and we are currently looking for a Regulatory Submission Manager.
To support our drug development activities, we work closely with relevant Health Authorities to facilitate the regulatory approval processes. We therefore seek a Regulatory Submission Manager to strengthen our regulatory activities across the range from early- to late-stage development and ultimately to regulatory filing.
- Responsible for preparing and coordinating regulatory submissions such as clinical trial applications, IND submissions, and amendments, NDA and MAA submissions, Health Authority meeting requests and briefing package submissions in collaboration with the Regulatory Lead, clinical CRO’s, and relevant functional area representatives
Orphazyme A/S, Copenhagen
Are you our new Clinical Operations Specialist (office-based) in a busy and ambitious working environment? This is your opportunity to join a dedicated team of professionals and become an important part of the Clinical Development staff of a progressive and innovative biopharmaceutical company.
- Operational support to the different trial teams (Clinical Project Manager/Trial Manager, Clinical Trial Administrator, other trial team members, CROs, and vendors) throughout the trial life-cycle (planning, conduct, and closure)
- Oversee and manage the CROs (e.g. oversight tasks, review study plans and project-specific templates, follow-up on CRO deliverables)
- Monitoring oversight (e.g. CRAs performance, review selected trip reports, co-monitoring)
- Ad hoc-tasks (support with TMF, internal meetings etc.)
LEO Pharma, Ballerup
If you have a solid understanding of guidelines across EMA/ICH/FDA, and you are looking for a job with great variety of tasks and global vision, you don’t have to look any further. At LEO you will be part of a successful and rapidly growing company, and you will join a well-functioning department known for team spirit, cooperation and genuine care for each other.
As Senior Pharmacovigilance Specialist your primary focus is to make sure that overall processes are maintained and optimised in order to submit/distribute case reports according to PV legislation and maintain a high compliance in relation to legislation worldwide. In overview your primary tasks will be to:
- Surveillance of outsourcing partner
- Maintain quality documents and processes (both for post marketing and clinical trials)
- SAE reconciliation and reconciliation of cases with affiliates and partners
AGC Biologics A/S, Søborg
QA Operations is looking for an experienced Director to assist with daily management of the Department and facilitate quality oversight and general compliance during manufacturing activities and batch release of biological intermediates and APIs for commercial / clinical trials.
As QA Operation Director, you will be involved in various daily operational tasks in a dynamic and challenging environment. The team handles review and approval of quality documentation e.g. Batch Production Records, Master Production Records, Specifications, QC analytical procedures, QC stability documentation, validation processes (PPQ manufacturing process and QC analytical method validations), Change Requests, Deviations and CAPAs.
Mercuri Urval recruiting on behalf of Fresenius Kabi in Sweden
An exciting opportunity to establish, build and expand an entirely new business area in the Nordics
Fresenius Kabi in September 2017 successfully acquired the entire development pipeline of Merck KGaA’s biosimilars, along with employees located in Aubonne and Vevey, Switzerland.
Accordingly the organization is now augmented, in a newly established position, with a Nordic Project Manager/Brand Manager that can take responsibility for the biosimilars portfolio.
In general, the job will include these areas:
- Manage the newly acquired Biosimilar business of Fresenius Kabi in the Nordics
- Assess and evaluate local market scenarios in order to prepare the Fresenius Kabi biosimilar launch i.e. identify success factors, key decision makers, purchasing system, patient flow etc.
- Prepare and define the business and marketing plan of the Biosimilar product range in the Nordic countries
Novo Nordisk A/S, Søborg
Being part of Novo Nordisk Research & Development means working at one of the world’s largest and most successful biopharmaceutical companies. This is the chance for a talented person with an interest in process optimisation and Standard Operating Procedure (SOP) development to join Global Clinical Compliance as our new Senior GCP Advisor.
Together with 8 colleagues, you will be responsible for ensuring that Novo Nordisk maintains one global clinical quality management system in compliance with GCP and other relevant external and internal requirements. You will be working in a dynamic department where flexibility on tasks is required. You will be GCP expert on the clinical SOPs in the SOP update process, provide GCP support to stakeholders and participate in cross-departmental working groups.
Unique Human Capital recruiting on behalf of Genmab A/S in Copenhagen
Exciting position in an ambitious biotech company
Genmab has a robust pipeline of innovative human antibody therapeutics and a number of strategic partnerships are already in place with international blue chip companies. The company is continuing its growth and development, striving towards its goal of improving the lives of cancer patients with unmet medical needs.
As Legal Adviser at Genmab you will be working as part of the international Legal Team to achieve key legal milestones necessary for the rapid growth of the company. The Legal Department employs 9 people located in Denmark, the Netherlands, and US. You will report to Senior Director; Head of Legal.
Ferring Pharmaceuticals A/S, Copenhagen
Would you like to join us in a challenging position as project statistician within the Biostatistics department of Global Biometrics?
The Biostatistics department is, next to Statistical Operations and Data Management, part of Global Biometrics. You will be working closely with peers located in the US, China and Japan. You will be reporting to the Senior Director, Biostatistics in Ferring Pharmaceuticals IPC, Copenhagen, and be part of a relatively small highly professional team.
As a project statistician, you will be overall responsible for:
- clinical trial designs (phases I-IV) and its operating characteristics
- programming preparations with primary focus on statistical inference
- central statistical monitoring using SAS JMP-Clinical functionality.
Are you passionate about working with clinical studies in an international environment? Then we have position a Study Start-up Manager in the Clinical Study Management department at Lundbeck. Clinical Study Management is part of Lundbeck’s Research & Development organisation and the position is based at Lundbeck’s headquarters in Copenhagen.
Your role will be twofold. First you will be responsible for the review and management of clinical trial agreements and site budgets during the negotiation phase. You will do that in close collaboration with our Clinical Research Organizations (CRO) and Lundbeck Legal. As the key contact person, you ensure a smooth communication between the Study Managers, CRO, and Lundbeck’s Legal department on the content and status regarding the contracts between clinical sites and Lundbeck.
At Novozymes, we work in close partnership with our customers and the global community to make a sustainable impact. We use science to advance industries, and as part of Research, Innovation and Supply, you will help find the biological answers and build the new businesses that can pave the way for a brighter future.
You will be optimizing processes based on scientific knowledge, lab investigations and production trials, and identify optimization leads from mathematical and statistical treatment and modelling of data. We typically work on projects of 6-12 months’ duration with focus on making significant and value creating process improvements. We work in projects with focus on team work. Our team includes 13 fermentation scientists and technicians.
The Aquatic Animal Health Unit, DTU National Institute for Aquatic Resources (DTU Aqua), Denmark is seeking a biologist or veterinarian with a strong scientific background to take part in the functions and duties of the European Union Reference Laboratory for Crustacean Diseases (EURL-Crustacean).
The successful candidate will take part in
- Research on the control, diagnosis, identification and characterization of Crustacean pathogens with special focus on the exotic and non-exotic diseases listed in Council Directive 2006/88/EC and on emerging diseases.
- Obtain ISO 17025 accreditation of the diagnosis of listed crustacean diseases.
- Establish experimental tank facilities for conducting trials with crustaceans.
Sanos Clinic A/S, Herlev
Sanos Clinic A/S is a newly established, dedicated clinical research clinic. In Sanos, we strive to deliver high quality clinical data in an innovative scientific environment, and to bring new medical treatments to the patients in need.
As a result of our growth, we are now looking for a physician qualified in Denmark to be a part of our team.
Your job as Clinical Research Physician is highly varied and will amongst other responsibilities include the following:
- oversee and be responsible for the conduct of clinical research that conforms with standards for Good Clinical Practice
- recruit and screen patients for clinical trials
- daily patient consultation
- contributing to trial protocol development and to feasibility assessments
På Solresor har vi höga ambitioner inom det digitala området och vi upplever en stark tillväxt på våra onlineplattformar. Vi letar därför efter en Traffic Manager med stort driv och som brinner för digitalt kampanjarbete.
Livet på en resebyrå innebär ett högt tempo och vi tror att frekventa kampanjer ger störst resultat. Rollen som Traffic Manager kräver att du är målinriktad och van vid högt tempo eftersom vi arbetar med många kampanjer samtidigt baserade på principen om trial and error.
- Planläggning och optimering av digitala kampanjer för alla varumärken inom Primera Travel i samarbete med nuvarande SEM Manager
- Optimera och underhålla sökkampanjer i AdWords och Bing
- Utföra kampanjer genom Paid Social, Programmatic och Google Display Network
- Rådgiva och vägleda kollegor med SEM och digital annonsering.
LEO Pharma, Ballerup
If you are interested in early stage drug development and skin disease this job could be a great opportunity for you.
Your overall objective is to contribute to the development of new drugs and treatments for people with skin diseases. You will support the organisation with medical input shaping early stage development of our project pipeline and explorative trials establishing new indications. You will unfold your skills in various project teams in a role as their Medical Expert. Your primary tasks will be to:
- Act as medical lead for Translational Medicine for disease indication development programmes
- Support clinical trials in early clinical development (Clinical Proof of Concept plans and clinical trials ranging from First in Human to Proof of Concept phase 2a trials)
- Analyse, interpret and report on data from clinical trials and literature
Clinical Trial Administrator
Zealand Pharma A/S, Glostrup
Zealand Pharma A/S is seeking an experienced Clinical Trial Administrator to the Clinical Operations department. The department is responsible for setting up, overseeing and directing clinical trials from early development phases to market approval, typically with the use of and collaboration with Clinical Research Organizations (CROs).
The department is part of Clinical Development and is composed of a dynamic team with enthusiastic and professional colleagues. We have an open and respectful working environment with great team spirit and high quality mind-set, encouraging knowledge sharing and development of people and processes.
Due to the increased number of new trials to be initiated, we are seeking a new experienced colleague to join our team.
DuPont Nutrition Biosciences ApS, Brabrand
For the group Oils & Fats, Beverage & Bars, Antioxidants in Brabrand, we are seeking a creative Application Specialist in a maternity leave position to assist us in servicing our external and internal customers. You will be part of the Beverage group – with an excellent industry team and global knowledge sharing allowing us to challenge what’s possible and what will be the preferred nutritional beverage in the future.
- Servicing mainly our European based customers within the beverage industry with focus on health and wellness and nutritional beverages (particularly non-dairy categories)
- Execution of customer related tasks in close collaboration with colleagues in the group and across the organization
- Evaluating new ingredients supporting product launches.
Novo Nordisk A/S, Bagsværd
Is drug safety important to you? Are you excited by digging into information to find answers? Do you want to play a key role in ensuring highest safety and lowest possible risk to patients that use Novo Nordisk products? You may be our new colleague in Safety Surveillance GLP1 Diabetes.
You will be responsible for the ongoing safety surveillance of one or more products used in the treatment of Type 2 Diabetes. This responsibility includes critical analysis and medical evaluation of the emerging safety data, establishment of the product safety profile during development and maintenance of the labelling for marketed products, and communication about the benefit-risk assessment. Once the analysis is done, you will be required to present the data to a group of highly experienced physicians, scientist and managers within the company.
A 3-year PhD scholarship is available at the Center for Fast Ultrasound Imaging (CFU) at the Department of Electrical Engineering from September 2018.
It is conducted in collaboration between CFU at DTU Elektro, DTU Nanotech, BK Medical, University of Copenhagen, and the Copenhagen University Hospital (Rigshospitalet).
The project seeks to develop new advanced ultrasound super resolution imaging (SRI) techniques. SRI can increase the fundamental resolution of ultrasound by a factor of 10-100 times using isolation and tracking of micro bubbles injected into the blood stream.
MAN Diesel & Turbo, Copenhagen
Will you be part of the test and development team for the future green ship low emission engines?
We are seeking superintendent engineers for our Two-Stroke Operation department in Copenhagen. You will be a part of a team of approx. 80 colleagues. The Two-Stroke Operation department holds a central position in our Engineering and R&D structure. The department is central in testing and troubleshooting on testbed and vessels in service. We attend physical around the world or by online remote access. The work involves close cooperation internal with our design and R&D dept. and external with our licensed engine builders, shipyards and ship owners.
- A varied and very interesting job with possibilities for both professional and personal development in an international business environment.
- Salary following qualifications, overtime payment and pension scheme.
- Fleksible working hours.
LEO Pharma, Ballerup
Would you like to play a key role in the development of our growing portfolio together with a friendly, ambitious and professional team of Clinical Trial Supply Professionals?
As a Clinical Trial Supply Professional you will join a very dedicated team, who is responsible for coordinating IMP outsourced related activities in connection with the conduct of Clinical Trials Phase I-IV. You will be working according to given company procedures and relevant GMP, GCP and regulatory requirements. You will also:
- Hold a strong understanding for IRT systems
- Provide input to the Clinical Trial Protocol
- Create SOPs and keep them updated