The Research and Technology Management team is seeking a Pharmacology and Toxicology Associate.
The successful candidate will be an enthusiastic, highly motivated, and innovative individual who is excited to join the extraordinary teams of scientists and clinicians at MSK that are united in a common pursuit: to transform our understanding of cancer and how we care for those affected by the disease!
To learn more about the amazing things the team at MSK is doing, click here .
As a Pharmacology and Toxicology Associate you will:
Review non-clinical study reports for completion, scientific soundness and regulatory suitability and prepare tabulated summaries for IND sections.
Participate in the writing and review of Pharm/Tox sections of institutional Investigational New Drug (IND) applications.
Co-ordinate and track progress of pharm/tox studies internally or at CROs; including CRO selection, qualification, study director interactions and study monitoring.
Participate in study, project team meetings, and assist the teams in resolving issues related to document preparation.
Be an expert user of the templates for non-clinical documents that are consistent with FDA and ICH guidelines and with electronic submissions guidelines.
Demonstrate knowledge about regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate.
Review work of other writers for accuracy, quality, focus and adherence to format and stylistic requirements in order to ensure high quality documents.
A Masters Degree in Biomedical Sciences, Pharmacy, Toxicology, Pharmacokinetics, Pharmacology or related Life Science discipline required.
A Doctorate Degree preferred.
Excellent technical scientific writing and verbal communication skills required.
Ability to analyze and provide constructive feedback on scientific data.
Experience with electronic document submissions (eCTD) for FDA preferred.
At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes. For the 28th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker’s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2018, as well as one of Glassdoor’s Employees’ Choice Best Place to Work for 2018. We’re treating cancer, one patient at a time. Join us and make a difference every day.