Carrer

The future is waiting for you!

We owe our success to the people who work for us.

With its products and services CO.DON sustainably improves the health and quality of life of its patients. Our innovative products and working methods would be unthinkable without motivated, qualified and team-oriented colleagues.

As an innovation leader in the highly dynamic regenerative medicine market we are looking for the best; people who will prosper in our creative working environment and make our corporate goals their own career goals.

CO.DON AG
Human Resources
Warthestrasse 21
14513 Teltow
karriere[at]codon.de

 

Global Value & Access Manager (f/m)

The biopharmaceutical company CO.DON AG headquartered in and near Berlin is one of the world's leading specialists in cell cultivation for the treatment of joint articular cartilage defects. The drugs for Advanced Therapy Medicinal Products (ATMPs) are manufactured according to GMP and AMG and used for the autologous treatment of cartilage damage.

For our headquarter in Berlin, we recruting for the earliest possible date a 

Global Value & Access Manager (f/m)

Summary of the position:

  • Develop and facilitate the execution of health economics and outcomes research (HEOR) strategies to generate further real-world evidence for CO.DON AG products
  • Collaborate on the development of added value & benefit argumentation
  • Support clinical development and study planning in view of HTA and Pricing & Reimbursement requirements
  • Engage in HTA dossier submissions across Europe
  • Engage in health policy on EU level

Objectives

  • Develop and execute HEOR strategies to optimise Market Access evidence generation
  • Drive HEOR projects, develop and execute tools
  • Develop HEOR communications (e.g. manuscripts, scientific forum presentations, slide decks) to build additional evidence supporting the value proposition
  • Translate clinical and HEOR information to evidence based value argumentation
  • Translate HTA requirements to clinical outcomes parameters in view of clinical study designs
  • Develop a best-in-class Core Value Dossier (CVD) and other global value material and ensure acceptance by local markets
  • Contribute to meetings with external bodies such as health technology assessment (HTA) agencies and engage with clinical and HEOR KOL to seek external input to further evidence generation strategies and plans
  • Collaborate with registries (e.g. ICRS) to facilitate long-term outcomes data
  • Evaluate health insurance data analysis (e.g. German GKV routine data)
  • Perform unmet needs analysis, perform evidence gap analysis, systematic literature research
  • Support cross-functional with Clinical Operations, Commercial, Medical Affairs, and Launch Teams
  • Support Sales in terms of reimbursement and payer communication (outside DACH region)
  • Engage in health policy activities on EU level

Qualification

  • Relevant life science or economics background, post-graduate qualification (e.g. PhD)
  • Solid understanding of health economics & outcomes research (HEOR) and clinical study design
  • Profound knowledge of the European health care systems including HTA procedures
  • Market Access launch experience
  • Excellent analytical and project management skills
  • Prior experience in pharmaceutical industry especially in the ATMP’s field would be an advantage
  • Proven ability to translate clinical and other benefits into evidence-based arguments and deliverables, e.g. publications
  • Ability to create strong networks and enjoy working in cross-functional teams
  • Fluent in both written and spoken English on a professional level
  • Willingness to travel across EU

 For further information please contact Mr. Grebe: m.grebe@codon.de

 

Qualfied Person (m/f) for the Leipzig production site

The biopharmaceutical company CO.DON AG headquartered in and near Berlin is one of the world's leading specialists in cell cultivation for the treatment of joint articular cartilage defects. The drugs for Advanced Therapy Medicinal Products (ATMPs) are manufactured according to GMP and AMG and used for the autologous treatment of cartilage damage.

For our new production facility in Leipzig, we recruting for the earliest possible date a 

Qualfied Person (m/f)

As a Qualified Person of CO.DON AG in accordance with § 15 AMG, you are responsible for the release and placing on the market of our pharmaceutical products and clinical trial materials.

Responsibilities:

 

  • Performing duties as a Qualified Person in accordance with § 15 AMG and Annex
  • 16 EU-GMP-Guideline
  • Certification and release of ATMPs and clinical trial materials in accordance with §
  • 16 AMWHV
  • Ensure GMP-compliant manufacturing and testing of our ATMPs over the whole
  • manufacturing process
  • Review and approval of the manufacturing- and testing-documentation in
  • accordance with Annex 16
  • Risk-based assessment of deviations, OOS, complaints and changes
  • Communication with the competent Health Authority, support of GMP-inspections
  • Contact person for quality-related issues raised by authorities and users
  • Execution of supplier- and self-inspections
  • Training of employees and sales representatives

 Your Profile:

 

  • University degree of Pharmacy, Biology or Medical Science, including the required
  • expertise in accordance with § 15 AMG
  • Several years of experience in the field of testing, manufacturing and/or release of
  • pharmaceutical products. Expertise in the field of ATMPs preferable.
  • In-depth knowledge of pharmaceutical law, GMP-requirements in the EU, and in
  • the field of Quality Management.
  • Self-employed, structured working methods, high degree of quality-awareness and
  • assertiveness
  • Very good communication skills in German and English, in verbal and written form
  • High degree in team ability

 Please send your comlete and meaningful application documents including salary presentations and the earliest possible date of entry to karriere@codon.de