- Daiichi Sankyo, Inc. (Bernards, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …goals. Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. ... ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion...to meet overall business need, while maintaining compliance with US regulatory requirements and company operating procedures… more
- Genmab (Plainsboro, NJ)
- …documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics ... best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices… more
- Merck & Co. (Rahway, NJ)
- …monitoring, analysis, regulatory reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre-clinical and ... colleagues while developing and expanding your career. - The Senior Director ( Senior Principal Scientist)...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- …leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a ... strengthen our pharmacometrics capabilities on a continuous basis. The Senior Director will be accountable for directing...in certain states and cities within the United States . Final determinations with respect to… more
- Genmab (Plainsboro, NJ)
- …FDA and other health authorities as appropriate Monitor and assess global and US regulatory guidelines and regulations and current regulatory ... be primarily responsible for the development of global (and US ) regulatory strategies (depending on the assigned...on the role for the assigned product Consult with senior management to develop and communicate regulatory … more
- Genmab (Plainsboro, NJ)
- …to an innovative and growing organization? At Genmab, we're seeking a Senior Director , Strategic Planning & Effectiveness to drive cross-functional ... in cross-functional and global franchise leadership meetings, escalating critical issues to senior leadership.Collaborate with the SVP to manage US Oncology… more
- Merck & Co. (San Diego, CA)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... that can be deployed in clinical trials. You will also support preparation of regulatory documents in support of clinical trials.- In addition, you will be the site… more
