Senior Medical Communications Scientist (Early Phase - Strategic Regulatory Writer) – Fixed Term Opportunity 6 months (or Secondment.)
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with integrity, even in the most difficult situations because we are committed to doing the right thing.
Our critical, core drug development expertise is at the heart of our three vibrant scientific centres in Gothenburg (Sweden), Cambridge (UK) and Gaithersburg (US). This is an exciting period for us, as well as for those poised to join us. Our strategy and ability to transform our portfolio means we have a pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines.
We are looking for a Senior Medical Communications Scientist to join us in Cambridge, UK or Gothenburg, Sweden. This is an exciting opportunity to author clinical regulatory documents that contribute to a clinical development program. This will be for a period of 6 months and can either be a fixed term contract (or for internal employees only, a secondment.)
Main Duties and Responsibilities
As a Senior Medical Communications Scientist (MCS), you will provide expert communications leadership drug projects and drive strategic medical writing, advocating communications excellence in your team. The MCS ensures that clinical documents align with project strategies, meet regulatory requirements and adopt best communications practices.
- Lead the authoring of clinical documents. Writes clinical regulatory and other supporting documents/submissions for assigned studies/indications for one or more programs/molecules, and manages the overall development and approval process. Critically analyses, synthesizes, and presents complex information from a broad range of scientific disciplines and therapeutic areas.
- Provide critical review of documents from authors assigned to document deliverables for correctness, clarity, completeness and compliance. Drives consistency across projects/programs.
- Manage service providers/contractors as needed.
- Lead continuous improvement within the department and across the organisation. Uses submissions-related expertise to improve document quality and process efficiency. Ensures adherence of document to standards and processes
To join us as a MCS, you should have a working knowledge and understanding of the drug development process within the pharmaceutical industry, together with significant experience in an international communications or information role.
In addition, you will have:
- Bachelor's degree in the life sciences, preferably with an MSc or PhD.
- Demonstrated regulatory writing experience gained within the pharmaceutical/medical industry/CRO.
- Willingness to undertake domestic and international travel as required by the project.
- Regulatory writing experience such as Clinical Study Reports.
This role is a 6-month fixed term opportunity, office based.
Location: Cambridge, UK or Gothenburg, Sweden.
Competitive salary and benefits.
Closing date for applications: 7th December 2019
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.