Senior CMC Documentation Lead, AstraZeneca Gothenburg

Job description
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

We are now recruiting Senior CMC Documentation Leads to join our Chemistry, Manufacturing and Controls (CMC) Documentation team. This is a consulting position at AstraZeneca in Gothenburg.

The CMC Documentation Group is a global group consisting of two teams, in UK and Sweden, who play a key role in ensuring that AstraZeneca’s CMC regulatory submissions for both clinical trials and marketing applications are delivered. The group manages a harmonised and effective authoring, review, approval and publishing process for the CMC elements of submissions and has accountability for the deliveries from Pharmaceutical Technology & Development (PT&D) and Pharmaceutical Sciences (Pharm Sci) to Regulatory Affairs.

Responsibilities
In this position you will support clinical trials for phase 1 to phase 4 and marketing applications to obtain our commercial manufacturing license. As a CMC Documentation Lead you will be a key member of the CMC 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.

In this role you will be accountable for leading 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. Your main responsibilities will include:
Define which CMC documents are required
Prepare and run the CMC Submission Kick Off and review meetings
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 CMC approval of all CMC documents to submission ready standards


Qualifications
Required Skills
A University degree, preferably Chemistry or Pharmacy
Experience using document management systems, e.g. CARA
Good understanding of the pharmaceutical industry and the drug development process
Excellent written and verbal in English
Experience of leading teams


Desired Experience
Experience of managing delivery teams and CMC regulatory documentation in a pharmaceutical company

To be successful in this role we believe that you have a can-do attitude and an ability to set and manage priorities, resources and project initiatives.

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-03-11, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information, please contact Linnea Öster linnea.oster@randstad.se

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!