Regulatory Submissions Jobs in Parsippany, NJ

The Senior Regulatory Affairs Manager - Screening will provide direct regulatory support for IVD cancer screening products (Shield CRC and future blood-based cancer screening tests) in all stages of the product lifecycle. This role will actively lead and support development and implem More...

Senior Regulatory Affairs Manager OncologyPosition SummaryThe Senior Regulatory Affairs Manager - Oncology will provide direct regulatory support for Oncology IVD/CDx products (Guardant360 CDx and future products such as Tissue IVD/CDx) in all stages of the product lifecycle. Th More...

Senior Regulatory Affairs Manager OncologyPosition SummaryThe Senior Regulatory Affairs Manager will provide direct regulatory support for Oncology IVD/CDx products (Guardant360 CDx and future products such as Tissue IVD/CDx) in all stages of the product lifecycle. This role will act More...

The Senior Regulatory Affairs Manager will provide direct regulatory support for IVD cancer screening products (Shield CRC and future blood-based cancer screening tests) in all stages of the product lifecycle. This role will actively lead and support development and implementation of More...

Ogilvy Health is focused on driving superior outcomes in the ever-changing healthcare environment an increasingly complex and evolving marketplace. We inspire brands and people to impact the world by keeping our audiences health and wellness needs at the center of every touchpoint. Og More...

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...

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We contin More...

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We contin 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...

Patient Solutions Engineer / Biomedical Design EngineerBe the driving force behind custom solutions that transform lives. This role lets you work on groundbreaking surgical implants and tools tailored to individual patientsoften pediatric and sarcoma cancer patientsgiving you the rare 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...