- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management (RPM) provides planning and drives coordination of global and US regulatory activities. The Associate Director RPM is responsible for ... centered around rare diseases and immune disorders. Summary: The Associate Director , Regulatory Affairs -...supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global … more
- 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
- 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 ... the company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be ... portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr...Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission.The Associate Director will have routine interaction with ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… 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)
- …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)
- …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)
- …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 Clinical Director (Distinguished Principal Scientist) has primary responsibility for the strategic planning and directing 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 ... 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 ... products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for continuous learning and personal development. Are you ready to maximize your potential with us ? The Position The Associate Director will be the lead who ... Reports to the Sr. Director , Patient Support Solution Quality/Safety Associate Director . Interacts with colleagues within Patient Support Programs, Patient… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …continuous learning and personal development. Are you ready to maximize your potential with us ? The Position The Associate Director , Data & Analytics ... skills to ensure vision is maintained across various NNI functions. Relationships The Associate Director , Data & Analytics Governance reports to the Senior … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and executing ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...alignment with the Evidence Generation Plan (EGP). Externally, the Associate Director RP will be the lead… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaborators, as we embark on shaping our future. The Position The Associate Director , HCP Experience has overall strategic and operational responsibility ... Nordisk Inc. (NNI)/North America Operations (NAO) and leads all US commercial efforts for Novo Nordisk's Rare Disease portfolio....to the Hemophilia Therapy Area Lead. Works closely with Associate Directors and Sr Brand Managers across the Rare… more
- Genmab (Plainsboro, NJ)
- …implemented, and utilized at a pace never seen before. Join Genmab as an Associate Director , Solution Architecture and Engineering, R&D Digital Products as part ... IT R&D Digital Products Team. This role will be reporting to the Director of Engineering and Solution Architecture, R&D Digital Products. The Solution Architect will… more
- Genmab (Plainsboro, NJ)
- …in a timely mannerExecute operational strategies related to drug supply, regulatory submissions, and recruitmentBudget and PlanningAssist in the initial development ... leading clinical projectsExperience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teamsSome experience with operational management and budget… more
