Regulatory Submissions Jobs in Edison, NJ

The Scientific Director International Medical Affairs - Gastroenterology provides medical and scientific strategic and operational input into core medical affairs activities including but not limited to: health-care professional and provider interactions; generation of clinical and sc More...

Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe support of international product registrations and related regulatory affairs activities including execution of procedures and More...

Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe support of international product registrations and related regulatory affairs activities including execution of procedures and sy More...

Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe support of international product registrations and related regulatory affairs activities including execution of procedures and s More...

POSITION SUMMARY:The InHouse Clinical Data Manager will be responsible for a range of data management tasks contributing to the success of clinical trials and regulatory submissions in accordance with Good Clinical Practices and applicable regulations including the Code of Federal Reg More...

General SummaryUnder limited supervision develops analyzes reports and interprets complex financial information to assist management in evaluating and executing the organizations business plans in compliance with the Health Services Cost Review Commission (HSCRC) and Center for Medica More...

About This Role:As a Medical Director Clinical Development Immunology you will be an integral member of the Immunology Therapeutic Area within the Clinical Development Organization. In this dynamic role you will play a critical part in shaping and advancing clinical programs particula More...

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...