Senior CMC Documentation Lead, Pharmaceutical Technology & Devel
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
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hela Sverige ALTEN Pharma in Gothenburg is looking for a Senior CMC Documentation Lead for a consultancy assignment at AstraZeneca.
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.
ABOUT ALTEN:
For over 20 years, ALTEN has developed its business by keeping to the core values ??that have built up the company's success. Every year, hundreds of ALTEN consultants have been given the opportunity to embark on challenging technical projects for our customers. ALTEN has a tradition of developing products in many areas, and history in Sweden is based primarily on skills in mechanics, software and electronics. Thanks to a successful concept in which we utilize the expertise of experienced consultants and develop young abilities towards a successful career, we have gained ground in many industries. Our Pharma initiative is based on the same successful concept with the same strong structure, but in a new exciting industry and a new field of expertise that includes knowledge in chemistry, biotechnology and biomedicine.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Rickard Westergren, Business Manager Pharma, at
rickard.westergren@alten.se.
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2018-02-20ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-02-26
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 3977353
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