Senior CMC Documentation Lead to AstraZeneca

Personality / Commitment

About AstraZeneca
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.

Job / Skills

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.

What we offer you at ALTEN
Every employee is equally valuable in the success of ALTEN! We are driven by making people grow and develop, which is why we offer you the opportunity to work with what you are truly passionate about. At ALTEN, we have a broad range of assignments at most of the leading companies in Sweden in several different sectors, to make it possible for your wishes to come true. We offer both national and international opportunities and together with your coaching manager, you build your career path so you constantly are able to develop and achieve your goals and dreams!

As a consultant at ALTEN, you will get the genuine team feeling at your assignment but also a wonderful togetherness at ALTEN. Through our different internal networks, such as ALTEN Sports, Women@ALTEN and ALTEN Innovation you will get the opportunity to drive topics and activities that are close to your heart, together with your colleagues. All activities are of course optional. Work life balance is our top priority. We also have a collective agreement and other benefits like Pension, Insurances and Wellness grants.

We believe in growing together!

Detaljer
Aktiverad vid 2019/12/02
Platser Gothenburg
Kontakt Matilda HOLTHE
Senaste dag för ansökning 2019/12/15
Referens AD008232