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. As a Medical Writer in Gaithersburg, MD , 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.
Main Duties and Responsibilities
You will be 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. You will work under direct supervision to manage and prioritize workload to ensure deliverables are completed per time and quality goals.
•You will assist in the writing/editing of clinical regulatory and other supporting documents for assigned studies/indications, and assist in the management of the overall development and approval process. You will assist in the analysis, synthesis, and presentation of complex information. You will provide QC review support as needed.
•You will assist in the writing of clinical abstracts, posters, and manuscripts for assigned studies
•Requires a PhD/PharmD in a scientific discipline, or a Master's degree with relevant experience.
Other Skills and Qualifications
•1-2 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.
•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.
•Willingness or ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables. Strong written, verbal, and interpersonal communication skills.
•Willingness or ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment. Flexible/willing to adapt to changing deadlines and priorities.
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our...cont.