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Zealand Pharma A/S
CMC Submission Project Manager

Zealand Pharma A/S, Søborg

Zealand Pharma A/S (Zealand) is looking for a CMC Submission Project Manager who is energized by working in close collaboration in teams on complex tasks with lots of fun and learnings.

You will be part of the very experienced CMC, Manufacturing and Submission team who is responsible for late-stage development and life cycle management activities.

You will be coordinating submission activities (mainly NDA/MAA submission in US/EU), while working in project teams together with other development functions. You will be working with several drug-device combination product submissions. Longer term there will be opportunity for leading project teams in drug development and life cycle management within CMC and Device.

Zealand Pharma A/S
Zealand Pharma A/S
Experienced Device Developer

Zealand Pharma A/S, Søborg

In Device Development we support the entire Zealand Pharma peptide portfolio, and we work with international partners to develop the best possible delivery devices for each of our drugs. We work as one team across multiple continents and across many functional disciplines. Two days are never the same.

The job includes execution and support to device development, device manufacturing and lifecycle management improvement projects for drug delivery devices.

You will be working with all aspects of device development for drug delivery. You are knowledgeable within Design Control and Human Factors testing, and you have experience in setting device requirements, doing Risk Management and planning and executing Design Verification. This involves both medical devices and combination products as well as their packaging and labeling.

Zealand Pharma A/S
Zealand Pharma A/S
HR Business Partner

Zealand Pharma A/S, Søborg

Our People & Organization team … well … We are awesome if we should say so ourselves. However, we are not going to lie. We are going through a huge transformation from being a back-end administrative function to becoming a proactive, leading business-driven HR department. We have gone a long way already, and we would like you to join us in reaching the finishing line. If you are not passionate about making things better for our organization, employees, and patients, you will hate it here! If you do exude passion, creative problem-solving, commitment, flexibility, and can-do-attitude, you will be a great fit. Ready to apply already?

You will be dedicated to a business area where you will identify and deliver on the HR agenda which supports the required strategic and operational business deliverables. You will advise, support and collaborate with stakeholders within and outside your business area on varying HR related matters.

Zealand Pharma A/S
Zealand Pharma A/S
Medical Director

Zealand Pharma A/S, Søborg

Do you have a medical background, experience from designing trials and drug development programs and a track record in clinical research and science within gastro-intestinal, rare diseases or metabolic disease areas? Do you have the drive and the talent for leading a medical and scientific project team? Are you motivated by supporting, learning and collaborating? Then you have the chance to become the Medical Director in one or more Zealand projects.

The Medical & Science department in the Development area consists of 4 Medical Directors and two Clinical Pharmacologists with diverse backgrounds. We are looking for a self-driven team-oriented colleague with the capability to lead cross-functional teams towards innovative solutions for delivering the highest standard clinical development program for our drug candidates. You will refer to the Head of Medical & Science.

Zealand Pharma A/S
Zealand Pharma A/S
QA Cooordinator

Zealand Pharma A/S, Søborg

We are looking for an experienced QA Coordinator in our Quality Systems team. The QA Coordinator collects, organizes, monitors and distributes information related to quality and process improvement functions, including but not limited to compliance to and documentation of quality management standards. Furthermore, the QA Coordinator participates proactively in the Quality System team to implement quality projects, follow up to obtain compliance, set standards for good recordkeeping, generate reports and using computer skills and communicate with suppliers and internal departments.

In Zealand QA we are a team of 12 and we act as Quality Partners for the GLP, GCP, GMP and IT area internally as well as quality oversight of our suppliers. The position is placed centrally at our headquarter in Søborg.

Zealand Pharma A/S
Zealand Pharma A/S
QA GCP Manager

Zealand Pharma A/S, Søborg

Zealand is now seeking a Clinial QA Manager with compliance insight to support and oversee our GCP activities and clinical operations at Zealand, with direct report to our QA GCP Director. You will be a part of a QA department that covers all aspects of QA covering Quality Systems, GxP IT, GMP & Device and GCP.

The successful candidate will be responsible for:

  • Ensure Zealand compliance with GCP and oversight of respective QMS/SOPs.
  • Provide GCP expert support/guidance to staff in support of GCP operations based on a high degree of knowledge of global industry expectations, GCP regulations and (20%).
  • Interpret GCP regulations and other external requirements and communicate to colleagues in organization to create solutions and reach a compliant level of operation.
  • Support and actively drive maintenance and further development of the Quality System within GCP area.
Zealand Pharma A/S
Zealand Pharma A/S
Medical Scientific Communications Manager

Zealand Pharma A/S, Søborg

Medical Affairs provides medical leadership with market preparation and partnership engagement on all Zealand Pharma products and therapies, and supports our internal stakeholders with medical insight and expertise. Medical Affairs aims to lead Zealand in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do.

Responsibilities include:

  • Support and conduct medical writing of Zealand clinical activities incl. phase 3 trials as per priorities
  • Manage the review and approval process of Zealand full manuscripts, abstracts and posters with internal and external authors
  • Chair publication teams and develop and execute publication strategy and plans
  • Manage medical writing agencies, contracts and budget
  • Manage conference planning and facilitate abstract/poster submission
Zealand Pharma A/S
Zealand Pharma A/S
Senior Evidence Generation Manager

Zealand Pharma A/S, Søborg

Medical Affairs provides medical leadership with market preparation and partnership engagement on all Zealand Pharma products and therapies and supports our internal stakeholders with medical insight and expertise. Medical Affairs aims to lead Zealand in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do.

Responsibilities include:

  • Support the planning and development of evidence generation initiative to better understand disease burden, patient pathway and outcomes for Zealand’s product portfolio
  • Provide input to clinical trial design e.g., inclusion of appropriate value/patient-reported outcomes endpoints
  • Develop and/or coordinate payer evidence tools (budget impact/cost-effectiveness models, value dossier and value messages)
Zealand Pharma A/S
Zealand Pharma A/S
Senior IT Cloud Engineer

Zealand Pharma A/S, Søborg

As Senior IT Cloud Engineer at Zealand Pharma A/S, you will work with the Director, Infrastructure, other IT colleagues, and stakeholders across the company to implement new cloud infrastructure solutions and support existing systems. The environment includes mostly Windows platforms, both on-premise and in the cloud.

Responsibilities include helping us to:

  • Planning, design, build, testing, and ongoing operation of secure global cloud infrastructure used by all employees.
  • Analyze and understand project requirements. Drive projects to completion.
  • Understand and effectively communicate risks associated with delivering or migrating to new technologies.
  • Engage in all phases of backup software and related storage solutions delivery including planning, design, build, testing, and ongoing operation.
Zealand Pharma A/S