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Associate Principal Medical Communications Scientist (Strategic Regulatory Writer)

Location Gaithersburg, Maryland, United States Gothenburg, Västra Götaland County, Sweden Cambridge, England, United Kingdom Job ID R-060638 Date posted 09/06/2019

Associate Principal Medical Communications Scientist (Strategic Regulatory Writer)

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 late stage pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines.

We are looking for an Associate Principal Medical Communications Scientist to join us at any one of our global sites. This is an exciting opportunity to author complex documents and submissions, take on strategic responsibilities and lead global authoring teams.

Role

As an Associate Principal Medical Communications Scientist (MCS), you will provide expert communications leadership to 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.

Responsibilities

  • You will lead the authoring of clinical documents. Writing clinical regulatory and other supporting documents/submissions for assigned studies/indications for one or more programs/molecules and manage 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. Drive 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. Ensurs adherence of document to standards and processes
  • Mentor staff, encouraging strong performance through motivation of others and leading by example.

Requirements

Essential

To join us as a MCS, you should have solid experience writing regulatory documents at study-level (ie, Clinical Study Reports), with a good understanding of pharmaceutical drug development.

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.

This role is available at Senior or Associate Principal career level, dependent on experience.

Competitive salary and benefits.

Closing date for applications: 6th October 2019

Next Steps -- Apply today!



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.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.