Regulatory Submissions Jobs in Indianapolis, IN

Responsibilities: Develop test and validate SAS programs to generate analysis datasets (ADaM) TLFs and adhoc reports. Ensure datasets and outputs adhere to CDISC standards and regulatory guidelines (e.g. FDA EMA). Collaborate with Biostatisticians Data Management and Clinical Teams More...

Leads preparation technical and regulatory review and finalization of CMC sections for global CTA submissionsTakes a proactive role in the critical review of molecule specific GRACMC development strategies and submission content. Makes technical decisions on CMC regulatory issues More...

Pharmacovigilance & Drug Safety Specialist (PharmD)Bring your clinical lens to the world of drug safety and reporting.Key Responsibilities:Analyze adverse event reports and clinical trial safety data.Prepare regulatory submissions (e.g. MedWatch PSURs).Collaborate with medical aff More...

Working with UsChallenging. Meaningful. Lifechanging. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the lat More...

Job DescriptionMedical Director Medical Monitor ObesityLocation: San Francisco Hybrid/Remote Option AvailableAbout the RoleA growing biotech company is seeking a Medical Director Medical Monitor to provide strategic medical oversight and ensure the successful of clinical trials. Th More...

Engagement Support Analyst Account Services***Unfortunately the Engagement Support Analyst is not able to provide sponsorship now or anytime in the future.******This role requires you to be located in the Indianapolis area because this is a hybrid role and requires one a day a week i More...

Are you a detailoriented professional with a passion for regulatory compliance in higher education Do you thrive in a fastpaced missiondriven environment where your expertise helps institutions maintain the highest standards of excellenceWe are seeking a Senior Licensing & Accredi More...

*Can be remote in the US or EUProvides specialist medical and scientific strategic and operational input into core medical affairs activities such as: healthcare professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value More...