Senior CMC Documentation Lead at AstraZeneca
Dfind Science & Engineering AB / Apotekarjobb / Göteborg
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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 consultant 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.
Business: Dfind Science & Engineering
City: Gothenburg
Deadline for applications: 2018-02-26. Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application at your earliest convenience!
For more information contact: Birgitta Nyström
birgitta.nystrom@dfind.se or Eleonor Ehrman 0733-434109
Please keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there.
Organization/Business description:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.
Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the worlds second largest company within recruiting and staffing.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-02-20ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-02-26
Ange följande referens när du ansöker: 201126309
Klicka på denna länk för att göra din ansökanKontaktEleonor Ehrman
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Östra Hamngatan 23
41110 GÖTEBORG
KontorsadressÖstra Hamngatan 23, 41110 GÖTEBORG
Jobbnummer 3977499
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