- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with decision-makers across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential ... human health starts here and that patients rely on us . We're changing lives for a living. Are you...Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational… 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
- 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
- Merck & Co. (Rahway, NJ)
- …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 ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre-clinical and ... Job DescriptionOur company in the United States and Canada, is a...and dedicated colleagues while developing and expanding your career.The Senior Director (Sr. Principal Scientist) has primary… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin us as an Executive Director of...in certain states and cities within the United States . Final determinations with respect to ... tax planning initiatives, positioning the company advantageously in the US and OECD regulatory landscapes.Cross-Functional Collaboration: Partner with… more
- Merck & Co. (Rahway, NJ)
- …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 ... collaborative relationships with stakeholders.Demonstrated ability to successfully negotiate with regulatory agencies and senior operations leaders; escalates… more
- Merck & Co. (Rahway, NJ)
- …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 ... cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. -- Specifically, the Director may… more
- Merck & Co. (Rahway, NJ)
- …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 ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …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 ... to clinical sites across more than 60+ countries, all in accordance with US and WW regulations, company policies and standard operating procedures. Without Clinical… more
- Merck & Co. (Rahway, NJ)
- …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 ... Job DescriptionWe are seeking a visionary Executive Director to lead our End-to-End Technical Leader organization and join the leadership team of Small Molecule… more
- Merck & Co. (Rahway, NJ)
- …an accredited institution - Required Experience and Skills: Registered to practice before the United States Patent and Trademark Office . Member in good standing ... access to life-saving medicines for patients? If so, the Director , Biologics Patent Attorney role , at our Company...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- …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 ... to clinical sites across more than 60+ countries, all in accordance with US and WW regulations, company policies and standard operating procedures.The head of GCS… more
- Merck & Co. (Rahway, NJ)
- …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 ... Job DescriptionThe Executive Director , Global Pharma Communications is responsible for leading,...Pharma Communications is responsible for leading, developing and executing US and global communications strategies and programs that support… more
- Merck & Co. (Rahway, NJ)
- …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 ... organization of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early Drug Development and/or… more
- Merck & Co. (Rahway, NJ)
- …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 ... Global Clinical Supply Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,-… 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
