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Senior CMC Documentation Lead

Ref: ZL_MODIS_001123

Den 02 December 2019

Modis Life Science is now looking for a senior CMC Documentation Lead for a consultancy assignment at AstraZeneca in GOthenburg. This is a consultancy assignment with start in january 2020 and last for 12 months. As a consultant you will behired by Modis. If you find the role interesting, send your application as soon as possible, no later than December 14. 

About the customer

AstraZeneca is a global, science-driven biopharmaceutical company. We are dedicated to discovering, developing, and delivering innovative, meaningful medicines and healthcare solutions that enrich the lives of patients. Pharmaceutical Technology and Development (PT&D) are the bridge, which turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.

The role

We now have a temporary position available for an individual who shares our passion to join the Regulatory Documentation team at Gothenburg. Documentation for the Chemistry, Manufacturing and Controls (CMC) part of submissions is one of the key project deliverables from Pharmaceutical Development (PT&D and Pharm Sci). The CMC Regulatory Documentation supports clinical trials and marketing applications to obtain our commercial manufacturing license. As a CMC Documentation Lead you will be a key member of the project team and have an opportunity to develop a deeper understanding of the regulatory processes, see the full range of Pharmaceutical Development documentation provided to authorities and lead teams across PT&D, Pharm Sci and regulatory departments in R&D and Operations.

Role responsibilities

Accountable within Pharmaceutical Development for the production and delivery of CMC sections of all regulatory documents e.g. marketing and clinical study applications, responses to Health Authority questions and briefing documents. The major tasks include

  • Define which CMC documents are required
  • Prepare for and run the CMC Submission Kick Off meeting
  • Lead the delivery team (authors, reviewers, approvers) for the CMC part of submissions
  • Lead the review process for all CMC documents, consolidating all comments
  • Drive the completion and on-time approval of all CMC documents to submission ready standards

Minimum requirements

  • A University degree or equivalent experience, preferably Chemistry or Pharmacy
  • Proven experience working in a science area with the drug development process involving regulatory documentation using Document Management Systems, e.g., ANGEL
  • Expert understanding of the pharmaceutical industry, drug development process, AZ departments and how they contribute to AZ processes to fulfill regulatory requirements.
  • Demonstrated strong interpersonal, motivational and leadership skills

               - A ´can-do´ attitude

  • Independent and calm under pressure
  • Confident leader and a clear communicator at ease of communicating with senior leaders
  • Results-focus and ability to deliver projects
  • Demonstrated ability to set and manage priorities, resources, goals and project initiatives.

  • Excellent written and verbal in English
  • Evidence of acting decisively, collaborative working, strategic leadership, commitment to customers and integrity, driving accountabilities with people at all levels and within drug product delivery teams.

For questions, please contact Cecilia Larzon (cecilia.larzon@modis.se)

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