- Daiichi Sankyo, Inc. (Bernards, NJ)
- …US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, ... Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience… 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 ... products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small ... will play a pivotal role in meeting cross-divisional and regulatory requirements by their strong scientific background, excellent communications...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- …Research & Division organization of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early Drug ... & Development pipeline and realize its full potential. The Associate Director is expected to provide project...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)
- …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
- 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 ... breakthrough science that radically changes the way we approach serious diseases. --The Director will report to an Associate Vice President in the Oncology… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …include management of all day-to-day payroll operations and activities for all US (multi-state) and Canada regions, ensuring compliance with company policies and ... Tax, Compliance and Legal team members to ensure compliance with all relevant regulatory , accounting, tax and internal requirements. This person leads the timely and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and programs to support the business functions of Daiichi Sankyo (DS) in the US , EU, Japan, and other global sites. These business functions include but are not ... to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance,… 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 ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction… 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 ... the indication of interest.Work closely with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs, statistics,… 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 Director of Biologics Potency in Analytical Research &...responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position… 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 pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Clinical Director May Be… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …meet its goals and objectives. This group also represents Gilead's commercial activities to US regulatory agencies. You will manage the commercial regulatory ... Join Gilead and help create possible, together. **Job Description** Regulatory Advertising and Promotion (RA Ad/Promo) is a core...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- Bristol Myers Squibb (Madison, NJ)
- …etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully ... **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that... . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- IQVIA (Parsippany, NJ)
- Job Overview Direct, oversee and manage complex regulatory projects, ensuring quality deliverables on time and within budget. Ensure that all project work is ... a Project Manager for a large stand-alone programme, involving several regulatory or technical deliverables and/or region, and/or operation; Undertakes risk… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, ... industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience with ex- US … more
