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Clinical Trial Manager til innovativt forskningsmiljø inden for hjertesygdomme og randomiserede studier

Er du en stærk analytiker med erfaring i at planlægge og udføre kliniske forsøg? Vil du være ansvarlig for at starte nye internationale kliniske forsøg op i Danmark sammen med vores samarbejdspartnere?

Kunne du tænke dig at arbejde med at gøre vores vision om kortere vej fra forskning til patientbehandling muligt?

Din opgave som Clinical Trial Manager vil være at lede implementering, udførelse og afslutning af kliniske forsøg i henhold til gældende studieprotokol og retningslinjer for Good Clinical Practice (GCP).

QA-specialist, der er QP-delegeret eller drømmer om at blive det

Drømmer du om at bidrage til at sikre kvaliteten af livsvigtige lægemidler, der redder liv? Er du en erfaren kvalitetsspecialist med erfaring fra lægemiddelproduktion?

Som delegeret Qualified Person (QPd) i vores Manufacturing QA (MQA) afdeling får du en unik mulighed for at arbejde med kvalitetssikring og frigivelse af Xellias produkter. Du vil være med til at sikre, at vores antibiotika når frem til patienter i hele verden i den højeste kvalitet. Som delegeret QP hos Xellia får du et stort ansvar.

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.

Automationsingeniør med erfaring indenfor Pharma

Vil du arbejde med spændende og varierende projekter indenfor automation og kunne du tænke dig at blive del af et dygtigt tværfagligt team, hvor humøret og ambitionerne er tårnhøje?

Vi arbejder i Pharma automation teamet dedikeret med design, programudvikling, indkøring, test og kvalificering af procesløsninger til vores pharma og biotech kunder og du bliver således en del af vores tværfaglige projektteams.

På kontoret i Kalundborg vil du indgå i et professionelt fagmiljø, hvor der er fokus på vidensdeling og det gode samarbejde. Din dagligdag bliver præget af gode kollegaer, faglige udfordringer og stor medbestemmelse.

Business Developer with a background in Science

Do you want to be at the forefront of Targeted Radiopharmaceuticals and Molecular Imaging?

We are looking for a professional Business Developer with a background in life sciences and the ambition to contribute to further strengthening Minerva Imaging as the trusted partner for targeted radiopharmaceuticals and molecular imaging.

What truly matters is your passion for the advancement and know-how of our scientific studies and your ability to foster long-term relationships with our collaborators.

Manufacturing Associate - Operator

We are looking for process operators, preferably with experience from a similar pharmaceutical production company or similar regulated businesses OR a Life Sciences Graduate who have recently finalized their Bachelor or Master degree relevant for Biologics Manufacturing and are keen on starting their career in a manufacturing and international environment where things move fast.

We are hiring for attitude, so we are looking for people who have a lot of drive and proven interest with working under GMP and enjoy working with numbers, math and IT tools.

Clinical Trial Assistant

Are you looking for the possibility to unfold your competences within clinical operations even further? Do you thrive in an innovative environment working alongside dedicated clinical research professionals? Are you a self-driven team player, who enjoys a varied and influential day at work?

Pharmacosmos A/S is a progressive and innovative pharmaceutical company with headquarters in Holbæk, Denmark. We are on an exciting journey of global growth inventing new and innovative treatments, and right now we are expanding our team with a Clinical Trial Assistant.

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 Specialist til QC hos Xellia Pharmaceuticals

Drømmer du om mere ansvar, med forskelligartede opgaver, og har du en passion for mikrobiologi? Vil du spille en central rolle i Xellias produktionen af livsvigtig antibiotika?

Som senior specialist vil du blive faglig ansvarlig for vores count release-laboratorie, som bl.a. udfører TVC- og LAL-analyser. Derudover vil du indgå i tæt samarbejde med vores sterile produktioner angående EM, hvor de nye Annex 1-krav stiller øgede krav til vores compliance, som du vil spille en vigtig rolle i.

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.

Biocompatibility Specialist

We are looking for a Biocompatibility Specialist to join the Reprocessing and Biocompatibility team for a 12-month project position.

This is a great opportunity if you would like to gain experience with biocompatibility for advanced reusable medical devices, as you will be part of a cross-functional effort on documenting the safety and performance through the lifetime of our ultrasound scanners, transducers, and accessories.

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.

Training Partner

Are you passionate about designing high impact training to improve ways of working?

The role will focus on re-designing the training related to onboarding our professionals working directly with our operation, our Operators, and our Laboratory Technicians.

You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words.

Ingeniør til validering

Vi har brug for en konsulent til et spændende job indenfor kvalificering og validering. Stillingen byder på mange forskellige opgaver og projekter hos vores kunder på det meste af Sjælland, og du får en spændende, travl og varierende hverdag.

Du vil bl.a. koordinere, planlægge og udføre validerings- og kvalificeringsprojekter, som kan omhandle: rengøringsvalidering, sterilisationsprocesser, procesanlæg, IT-validering, klimafaciliteter, produktions-, måle- og laboratorieudstyr.

Associate Sensory scientist/Sensory Panel Lead - Arla Innovation Centre, Aarhus

We are looking for two new Sensory Panel Leads. One new collegue for a 1 year maternity cover and one for a 3 year project. For both positions we hope we will be able to prolong the employment or offer new challenges within Arla Foods.

Your key responsibilities will be:

• In close contact with stakeholders, guide and choose the proper test-setup to deliver the sensory results needed
• Panel training and development of panel competences within specific areas of interest

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.

Dedikeret farmakoepidemiolog til Lægemiddelstyrelsens Dataanalysecenter

Lægemiddelstyrelsen er en helt unik arbejdsplads, i at vi er Danmarks eneste regulatoriske myndighed for lægemidler og medicinsk udstyr. Med denne position følger et helt særligt ansvar, som vi er meget stolte af og bevidste om i vores arbejde.

Dine primære arbejdsopgaver i Lægemiddelstyrelsens Dataanalysecenter er bl.a.:

• Designe, planlægge og udføre farmakoepidemiologiske analyser på sundhedsdata bl.a. vedr. forbrug, effekt og sikkerhed
• Udarbejdelse af rapporter, notater og præsentationer til forskellige målgrupper

Administrativ laborant

I prøvemodtagelsen registreres alle laboratoriets prøver, kemiske såvel som mikrobiologiske. Der er i prøvemodtagelsen ikke noget analytisk arbejde.

Vi søger en kollega med et stærkt udviklet servicegen, som vil bidrage til teamet. Dine arbejdsopgaver vil bestå af modtagelse, registrering, auditering og distribution af indkomne prøver samt afvigelsesbehandling.

Du vil blive en del af et engageret team på 5, hvor tingene ofte går stærkt, men hvor der også er tid til humor.