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Senior Specialist Clinical Safety and Pharmacovigilance (CSPV)

At Bavarian Nordic, we aspire to save and improve lives by developing innovative vaccines that are designed to unlock the power of the immune system.

The global team consists of subject matter experts for vaccine safety who work either from our site or remotely in Denmark and globally. Together they constantly collect and assess data for the life cycle benefit risk management across our vaccines whether authorized or still in clinical development.

You would add your clinical safety and pharmacovigilance expertise as your depth knowledge of the PV legislation to the team.

Customer Success Specialist

Brænder du for at sikre tilfredse kunder, er struktureret, glad for systemer og processer, og er tovholderen der får enderne til at mødes?

Ansvarsområder:

• Ordrehåndtering, levering og fakturering
• Kommerciel superuser på virksomhedens ERP- og CRM-systemer

Vi tilbyder et sjovt og uformelt miljø med stor fokus på sammenhold og fællesskab.

Postdoc in Biotechnology – DTU Chemical Engineering

Department of Chemical and Biochemical Engineering invites applications for a position as Post Doctoral Fellow to be hired within the frame of a project on biogas conversion to single cell protein in the form of methylotrophic bacteria, where optimising synergistic microbial interactions is a key element.

Project focus is on recovery of nutrients from the biogas digestate by microbial or electrochemical methods.

PhD scholarship in Bioinformatics of the Glycosylation Machinery of Archaea - DTU Bioengineering

DTU Bioengineering seeks a qualified candidate for a fully funded 3-year PhD position within Bioinformatics Based Mapping of N-Glycosylation of Proteins in Archaea. The PhD project is part of a Marie Sklodowska-Curie doctoral training Program, GLYCO-N, funded by the EU (MSCA Doctoral Network).

The PhD project is thus part of a bigger interdisciplinary research effort that aims to 1) Understand the diversity and structural complexity of archaeal, microalgal and viral N-glycosylation and 2) Harness this knowledge for new solutions in biomedicine and biotechnology.

IT Infrastructure Engineer

As an IT Infrastructure Engineer at Zealand Pharma A/S, you will implement new infrastructure solutions and support existing systems.

Responsibilities include:

• Provides day to day support of overall infrastructure including network, physical and virtual servers, hypervisors, and storage platforms.
• Configures and implement new systems and enhancements to existing systems in support of business needs.

Research Analyst

Are you in the right job? Do you want a challenge out of the ordinary?

The Primary Research Analyst has the responsibility of identifying, developing, and maintaining a network of contacts and relationships in the pharmaceutical and biotech industry and organizations.

An academic background in pharmacy or in biotechnology is an advantage but not a necessity as extensive internal training will be provided.

(Senior) Drug Substance Specialist

We are currently seeking a (Senior) Drug Substance Specialist who is energized by collaborative and fun teamwork, excels in handling complex tasks, and enjoys continuous learning.

Your responsibilities will include late-stage drug substance development, up-scaling and process validation as well as support in the commercial phase. Effective coordination with external partners is a significant aspect of this role.

Senior Associate Accounting Operations

Are you passionate about biotechnology and quality assurance? Genmab is offering a great opportunity as a Senior Associate Accounting Operations

The Finance area of Genmab is growing and now looking for a Senior Accountant to join the Accounting Operations team in Copenhagen.

This is a key position within the Accounting Operations Teams and a great opportunity for an experienced, motivated, and ambitious accounting professional. You will be working in a highly motivated team of experienced finance professionals in an organization where we value innovation, determination, integrity, and teamwork.

Senior LIMS Specialist for Global QC Development

In this role you’ll make an impact by working as a Senior LIMS Specialist in our team, where you will take part in management of projects for LIMS changes across QC laboratories and other stakeholders including implementation, documentation and communication.

Future projects could be introducing and validating LIMS solutions on new equipment or technologies, new LIMS functionalities, improving and aligning existing processes.

Regulatory Affairs Clinical Specialist

Due to many activities in our exciting clinical development projects, we are seeking two new colleagues to our Regulatory Affairs function.

Your key responsibilities will be to contribute with regulatory expertise to global strategies and execution within your assigned project(s). You will be the regulatory responsible in the clinical trial teams and provide regulatory guidance and support for the planning, execution, and reporting of clinical trials worldwide.

Senior Medical Writer

Do you want to work in a global context and according to the highest standards of current practice to provide new products to patients with unmet medical needs?

As a Senior Medical Writer, you will be responsible for delivering submission-ready documents and take the role as lead medical writer on specific assignments. In addition, you can look forward to joining a diverse organisation shaped by cross-functional and global collaboration – and a focus on continuous transformation to support the future needs of clinical development.

Regulatory Affairs Specialist

The RA Specialist for Radiometer is responsible for ensuring coordination of regulatory activities for a few of our Blood Gas products manufactured in California to help ensure continued compliance in all markets.

In this role, you will have the opportunity to:

• Facilitate coordination of regulatory activities between California and Denmark for design control activities and international registrations for a few of the instruments/consumables manufactured in our California site.
• Ensure compliance with EU regulations.
• Generate STED files, international submissions & assess design changes.
• Plan and execute projects for new regulatory requirements.

Senior Regulatory Specialist

The Senior Regulatory Affairs Specialist at Radiometer is responsible for collecting and generating documentation for product submissions to ensure compliance with international regulations. This role is critical for ensuring that Radiometer's products can be sold in markets around the world.

If you thrive in a fast-paced environment, are used to playing a critical supporting role and want to work in a world-class efficient team that is part of a Global RA department and have interactions and stakeholders to connect with in a global scale - read on.

Regulatory Affairs Manager

The Regulatory Affairs Manager at Radiometer is responsible for managing the preparation and submission of the required documentation for product registration, approval, and compliance with international regulations.

This role is critical for ensuring that Radiometer's products can be sold in markets around the world. You will have the opportunity to:

• Ensure regulatory compliance to maintain market approvals
• Lead a team of skilled RA associates
• Ensure alignment with relevant stakeholders