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Senior Vice President, Global Chief Medical Office

We are seeking a highly experienced and dynamic medical executive to join our Global Research & Development organisation in a newly established senior leadership role as SVP, Global Chief Medical Office (GCMO).

In this role, you will act as scientific advisor to the EVP of R&D and the Global R&D leadership team, and your primary objective will be to ensure “one global medical voice” for ALK internally and represent the medical voice of ALK externally.

Specialist, Regulatory Affairs (Temporary Position)

As Regulatory Affairs Specialist, you will be responsible for lifecycle management of products manufactured at Orifarm’s own manufacturing sites. Therefore, you will collaborate closely with colleagues across functions, such as chemists, formulation specialists and co-workers within Quality, Supply Chain, Manufacturing and Sales.

Further, your main responsibilities include to:

• Gather information and documentation for variation applications
• Update dossier sections

Senior Data Manager

The Senior Clinical Data Manager is responsible for leading and overseeing data management activities associated with clinical trials, ensuring data accuracy and consistency, and managing data cleaning and quality control processes.

We strongly endorse a flexible working environment around its core working hours of 09:00-15:00 and endorses fair and equal pay practices.

Application Specialist – Beverages

Are you passionate about product development within all types of beverages from premium organic CSD's to flavored spirits?

You will work in a high-paced, collaborative and energetic environment optimizing key elements of beverage applications such as taste, stability, preservation and appearance with the goal to design the perfect balance between these elements.

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.

Technical Specialist, Product Quality, Nourish (Maternity cover, 12 months)

Are you an enthusiastic, motivated and detail-oriented professional with a desire to work in a team of colleagues with great technical competencies within production, regulation and processes?

Your core responsibilities:

• Handling deviations for products manufactured at our factories.
• Handling of product quality related complaints.
• Coordinate and implement customer-specific requirements. Maintenance of master data in various IT systems, including SAP.

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 & QA Lead

Har du lyst til at blive en del af en spændende arbejdsplads, som opererer globalt med nogle af markedets bedste produkter?

Som vores Regulatory Affairs & QA Lead bliver du en del af et velfungerende team med 5 engagerede kolleger, der hver dag arbejder målrettet og brænder for deres arbejde.

Der kan være mange indgangsvinkler til jobbet men du skal have erfaring med medicinsk udstyr, være omhyggelig, energisk og brænde for det regulatoriske arbejde.

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

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.

Technical Writer to GE HealthCare Denmark

Join GE HealthCare to help develop high quality instructions for use for our ultrasound scanners, transducers, and reprocessing methods in compliance with rules and legislation in various countries. This is your opportunity to become part of an innovative team where your work has a real impact on people’s lives around the world.

Our Technical Documentation team consists of six dedicated and passionate specialists with a mix of seniority, educational backgrounds, and nationalities. Our Technical Writers develop and maintain the user documentation for our high-performance equipment.

QA Specialist

You will be responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms.

You will have the opportunity to:

• Provide Design Control guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.
• Represent Quality Assurance in design and development projects and in cross-functional teams supporting new product development.

Engineering Project Manager

Har du en passion for at drive teknologisk udvikling og bruge dine kompetencer i den grønne industrielle omstilling?

Den succesfulde kandidat vil have en ledende rolle i ALGIECEL's full-scale demonstrationsprojekt, der transformerer CO2-emissionerne på Novonesis' faciliteter i Kalundborg til bæredygtige algebaserede produkter gennem en yderst effektiv og kompakt fotobioreaktor.

Tiden for forandring er nu, og dette er din chance for at blive en del af vores højt motiverede team!

Senior Technical Writer - Regulatory (CMC)

You will join the Technical Writing team within Global Regulatory Affairs. We are responsible for global regulatory CMC writing of regulatory documents in applications for new approvals, worldwide market expansions, and product lifecycle activities. We work with a variety of pharmaceutical products, including small molecules, peptides, biologicals, recombinant products, and gene therapy.

Stepping into an informal and collaborative environment, you will have close interfaces with many different disciplines, including Global Pharmaceutical R&D, manufacturing sites, Product Supply, Quality Assurance, Ferring affiliates, and development sites around the world.

MS&T Program Manager

We are looking for an experienced professional from the pharmaceutical industry, who can effectively manage project plans across multiple entities and lead cross-functional processes within our own sites and supply chain.

As a MS&T Program Manager, you will be responsible for managing the projects, maintaining project databases, as well as ensuring effective communication and timely achievement of milestones.

Manufacturing Science & Technology (MS&T) Technical Transfer Project Manager (Sr Specialist)

Join Orifarm and take charge of building strong business relationships with a key portfolio of our suppliers!

As a MS&T Technical Transfer Project Manager, you will be responsible for securing technical support to Supplier Relationship Management functions, and manufacturing sites comprising support, technological transfers between CMOs and own manufacturing sites, analytical method development and validation, external product development at CDMOs and driving continuous technological improvement and innovation.

Protein Chemist for production of antibodies for cancer diagnostics

Do you find antibody production exciting?

You will play a key role in daily support of the production of conjugates. This can include:

• Support lab techs in case of technical issues with purification, conjugation, and test of antibodies.
• Handle compliance issues according to GMP standards.

We offer a high degree of freedom and development opportunities in an international company.

Analyst and Project Coordination In Life Science Consultancy

Would you like to work with data analysis and research of worldwide trends in the pharmaceutical and biotechnological industries?

You will get the responsibility of managing and coordinating the day-to-day operations needed to solve our projects and writing reports for our commercial unit.

An academic background in life science (pharmacy, biotechnology etc.), economics or similar is required.

Erfaren QA-Specialist – til frigivelse af produkter

Stillingen byder på et bredt udsnit af QA-opgaver og flere kan komme til, så du får gode muligheder for at videreudvikle dine QA-kompetencer.

Opgaverne:

• Selvstændig frigivelse af PKC’s produkter og behandling af afvigelser og håndtering af ændringssager
• Sparringspartner for QA-gruppen, QC-gruppen og produktionen

Du får ansvar for og stor medbestemmelse over dine opgaver. Der er tid til fordybelse, men der er også dage, hvor det går rigtig stærkt, og opgaverne blev andre end dem, du havde planlagt og forventet.