Eli Lilly

Responsible for triage of Lilly affiliate inquiries and requests and when necessary, consults with CMC RA Scientist for guidance in effort to prepare responses to questions.

Clinical Development Organization, a division of Lilly Research Laboratories, partners with colleagues in Research, Oncology, Biomedicines, and Diabetes to effectively and efficiently design, plan, and execute clinical trials across all phases of research. Uniting authorities in clinical development and design, laboratory and data sciences

Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.

The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Clinical Trial Project Manager Associate leads the cross-functional study team in the development and execution of clinical trials and is accountable both regionally and globally to deliver trials with quality, on time, and within scope and budget. Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies

Ensure submission and approval of high-quality regulatory applications within planned timelines and Facilitate interactions with regulatory bodies on a regular basis for approvals.

The individual has experience in handling various analytical techniques such as such as HPLC, GC, CE-SDS, SEC, ELISA, qPCR, DSC, Bioassay, Karl Fischer, UV, LC-MS, Dissolution, Disintegration, X-ray diffraction, etc.

Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment internally and with external partners. Demonstrated learning agility, and ability to think creatively, try new ideas and apply learnings and strong problem-solving skills.

Bachelors degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy