Senior CMC Documentation Lead
Modis Sweden AB / Läkarjobb / Mölndal
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hela Sverige Senior CMC Documentation Lead, Pharmaceutical Technology & Development
The arena
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 position available for an individual who shares our passion to join the Regulatory Documentation team in Gothenburg or in Macclesfield. 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 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.
What do we offer?
Modis Life Science is a specialized Business Line within Adecco Group. We work exclusively with Staffing Services and Recruitment of personnel within the Life Science industry. Our expertise lies within all areas of Life Science such as R&D, Production, Quality Assurance, Clinical Research, Regulatory Affairs, Medical Affairs, Marketing & Sales and many more. Our customers are companies, of different sizes, within the Pharmaceutical-, Biotech- and Medtech- industries. As the largest recruiting and staffing company in the world our most valuable assets are our consultants. With us, you as a consultant will be appreciated for your difference-making competence within Life Science!
Modis Life Science can offer you the opportunity of interesting assignments and positions at attractive companies that perhaps never will be put out on the open market! For your security as a consultant, you are covered by our collective agreement and by insurance and corporate healthcare. We also want you to stay healthy and therefore offer you healthcare contributions and discounts on training cards. We arrange social activities continuously where you are able to share your experiences with our other consultants.
Are you interested?
Then you should apply as soon as possible. The position is soon to be filled and therefore work with recruitment is being done on a continual basis.
Unfortunately, we cannot accept applications through e-mail, but if you have questions regarding the position contact Nalin Yilmaz,
nalin.yilmaz@adecco.seWe look forward to your application!
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2018-02-20ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-03-09
Klicka på denna länk för att göra din ansökanKontaktNalin Yilmaz
Nalin.Yilmaz@modis.seFöretagModis Sweden AB
AdressModis Sweden AB
Postgatan 28
41110 Göteborg
KontorsadressPostgatan 28
Jobbnummer 3977311
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