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Location:
Gaithersburg, Maryland, United States
Job reference: R-033254
Posted date: Oct. 02, 2018
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If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  Here at MedImmune, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.

MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Location

MD, Gaithersburg - Corporate Headquarters

Job Description

For Medical Writer:

Position Summary:
Responsible for assisting in the development of high-quality clinical regulatory and other supporting documents for pipeline and/or marketed products as well as assisting in the development of high-quality clinical abstracts, posters, and manuscripts. Works under direct supervision to manage and prioritize workload to ensure deliverables are completed per time and quality goals.

Major Duties and Responsibilities:

  • Assists in the writing/editing of clinical regulatory and other supporting documents for assigned studies/indications, and assists in the management of the overall development and approval process. Assists in the analysis, synthesis, and presentation of complex information. Provides QC review support as needed.
  • Assists in the writing of clinical abstracts, posters, and manuscripts for assigned studies

For Sr Medical Writer:

Position Summary:
Responsible for developing high-quality clinical regulatory and other supporting documents for pipeline and/or marketed products as well as developing high-quality clinical abstracts, posters, and manuscripts. Works under general supervision to manage and prioritize workload to ensure deliverables are completed per time and quality goals.

Major Duties and Responsibilities:

  • Writes/edits clinical regulatory and other supporting documents for assigned studies/indications, and manages the overall development and approval process. Critically analyzes, synthesizes, and presents complex information. Provides QC review support as needed.
  • Writes clinical abstracts, posters, and manuscripts for assigned studies
  • Works with service providers/contractors as needed for delivery of assigned documents.

Position Requirements

Education:

  • Requires a minimum of a Master's degree with relevant experience
  • PhD/PharmD in a scientific discipline preferred

For Medical Writer:

  • 1+ years experience in the medical/regulatory/publication writing field in the pharmaceutical/biotech industry or CRO environment. High attention to detail is a plus.

For Senior Medical Writer:

  • 2+ years of experience in the medical/regulatory/publication writing field in the pharmaceutical/biotech industry or CRO environment. High attention to detail is a plus.

For both:

  • Authoring/editing CSRs and other types of clinical regulatory documents (eg, clinical protocols, Investigator's Brochures) or scientific publications including abstracts and posters is a plus. 
  • Knowledge of Microsoft Office applications and electronic document management systems is a plus.
  • Knowledge of the drug development process and principles of GXP/ICH/CTD and other global standards, with an understanding of the basic strategy for regulatory submissions is a plus. Background in biologics a plus.

    Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation

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    Medical Writer/Senior Medical Writer
    MedImmune

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    • MedImmune, Gaithersburg, Maryland, United StatesRemove