MedImmune Operations Associate - (Gaithersburg, MD) in Gaithersburg, Maryland

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 Operations Associate 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

As Operations Associate, you will be part of Medical Writing Operations (MW Ops) and responsible for providing overall operational support in development, approval, and filing of clinical documents for regulatory submissions within the Medical Communication (MC) Department. You will work under general supervision to manage and prioritize workload to ensure deliverables are completed per time and quality goals. You will contribute to Clinical Study Report (CSR) production, including Section 14 and Appendix 16 document collection, assembling, and uploading to the electronic document management system (EDMS) and pre-publish CSR as per MW Ops process. Perform PDF checks for Adobe Acrobat documents to meet submission-ready standards for global Health Authorities. You may assist in formatting diverse scope of documents in TRS/ISIWriter, MS Word, and perform document cleaning activities to meet submission-ready standards for global Health Authorities as needed. Assist colleagues in document formatting troubleshooting for a diverse scope of documents in MS Word and Adobe Acrobat applications as needed. May perform quality control (QC) review of clinical regulatory and other supporting documents as needed. Submit clinical regulatory documents authored within MC Department to the Trial Master File and maintain records for submitted documents. Provide training to colleagues as needed. Participate in department, project, and MW Ops team meetings. Collaborate cross-functionally and contribute to continuous improvement within the MC Department and across the organization.

Essential Requirements

  • BA/BS degree or equivalent work experience in medical writing or regulatory submission field for pharmaceutical industry or CROs.

  • Ability to format clinical, medical and/or scientific documents as well as do PDF checks.

  • Proficiency in using Microsoft Office 2003-2013, Adobe Acrobat Professional, and TRS/ISIWriter Toolbox applications and working in EDMS environment.

Desirable Requirements

  • BA/BS degree in scientific discipline.

  • General understanding of the drug development process, clinical regulatory document types, the principles of GXP and ICH guidelines, and applicable standards.

  • Ability to identify and solve the problems.

  • Ability to manage and prioritize multiple projects under general supervision and work in a fast-paced environment.

  • High attention to detail.

  • Strong English written, verbal, and interpersonal communication skills.

  • Experience working across multiple disease areas and technical disciplines.

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 Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.