- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director , Regulatory Operations - Dossier Planning is ... of the US Dossier Planning team. The Associate Director provides leadership and oversight to...INDs, original and supplemental NDAs/BLAs/MAAs. The Associate Director partners with the Head of Regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated ... drug/diagnostic regulatory and submission plans), including HA engagement plans and...to 10% Occasional travel to Health Authority meetings in US and Europe, potentially Japan Daiichi Sankyo, Inc. is… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- 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, ... Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… 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 ... alignment with the Evidence Generation Plan (EGP). Externally, the Associate Director RP will be the lead...required. The incumbent can work remotely anywhere in the United States with reasonable access to an… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Summary The Associate Director is responsible for developing RWE strategies for assigned product(s) and ... Eisai Salary Transparency Language:The base salary range for the Associate Director , Global RWE (Real World Evidence),...the employment eligibility of all new hires in the United States . Please click on the following… more
- Merck & Co. (North Wales, PA)
- …the Research & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug ... progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and… more
- Merck & Co. (North Wales, PA)
- …commercial activities that interface with internal and external stakeholders, including US Medical Affairs, Regional Vaccine Medical Directors, Global Marketing, the ... review processes) including experience including bringing materials through legal, regulatory , and clinical review Strong project management skills as demonstrated… more
- Merck & Co. (North Wales, PA)
- …trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the ... of clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members through… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description Associate Director , Automation The Associate Director Manufacturing Automation is responsible for managing the team ... supply of product and on time project executionProviding direct support for regulatory inspections and audits and other validation activities by serving as the… more
- Insmed Incorporated (San Diego, CA)
- …to the Executive Director of Program Management, the Associate Director , Program Management supports the cross-functional drug development ... 2023, we became Great Place to Work-certified in the US for the third year in a row. We...in accordance with the program strategy. In addition, the Associate Director of PM may be asked… more
- Merck & Co. (North Wales, PA)
- …innovative medicines that help people around the globe. We are currently recruiting for Associate Director , US Marketing, HCP Strategy for HIV. Our company ... align on decisions, including field sales, marketing operations, Legal, Regulatory , Medical, etc. Our US marketing team has adopted an Agile operating model to… more
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... plans).Collaborate with cross-functional teams (eg, brand, HEOR, market research, sales, regulatory , legal, field market access teams) to develop aligned market… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Represent Device Development… more
- Merck & Co. (North Wales, PA)
- …you collaborate with copy, design, UX, architecture, internal legal, medical and regulatory teams in the co-design, co-creation, and execution of campaign plans ... of disease transmission.Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion,… more
- Merck & Co. (Rahway, NJ)
- …the organization in 2023.We are seeking a leader to take the position of the Associate Director Global Marketing, who will be responsible for maximization of the ... late lifecycle opportunitiesSupport filing of new indications and other regulatory requirements, such as pediatric filingsCross-functional collaboration: foster strong… more
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical Development ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams of… 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 ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
