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 Science Submission Manager (non-clinical writing) 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 function as a member of the Research Science Submission Management (RSSM) team and, independently and with limited guidance, work with Research Scientists and manage the preparation and review process of documents for the nonclinical modules of investigational new drugs (INDs), clinical trial applications (CTAs), biological license agreements (BLAs), and marketing authorization applications (MAAs). As a member of the SSM team, you will coordinate and consult on nonclinical regulatory filings, writing processes, and initiatives to advance the MedImmune pipeline and support marketed products.
With limited guidance, you will independently perform the following tasks: Prepare and manage summary sections for INDs, CTAs, BLAs, MAAs, research reports, responses to regulatory agencies, briefing books (nonclinical content), and IND/CTA life-cycle management. You will identify and resolve issues to reach consensus in submission preparation. You will actively participate in project team meetings, manage preparation and editing of documents prepared by junior staff and service providers. You may lead template and procedure preparations and provide guidance to staff on regulatory submissions and research reports.
Ph.D., or equivalent, in a scientific discipline relevant to research and drug development, such as pharmacology, biochemistry, pharmacokinetics, or toxicology.
- Master’s degree in a scientific discipline is acceptable with 4-5 years of laboratory work experience.
- 3-4 years of biopharmaceutical industry experience, including two or more years of writing experience
- Experience with electronic submission systems, editing and reviewing large
- Post-doctoral experience, as well as 1-2 years of direct supervisory experience in similar position
- Experience preparing nonclinical regulatory documents and manuscripts
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.