- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for ... and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess...and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other aspects of drug … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …preferred Minimum of 8 years total pharmaceutical/related industry experience in drug development required Demonstrated knowledge of global regulatory ... regulatory agencies, including the FDA Experience with rare disease drug development, innovative trial design and/or expedited regulatory pathways, highly… more
- Merck & Co. (North Wales, PA)
- …both a system and process prospective.Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits.Lead efforts to ... with International Pharmacovigilance community and external customers to ensure regulatory compliance for both expedited and periodic reports.Collaborate closely… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory ... and Controls) activities of the portfolio small molecule and biological drug products consistent with the company goals; specifically, for the life-cycle… more
- Merck & Co. (South San Francisco, CA)
- …company's Research Laboratories in South San Francisco is seeking an Associate Principal Scientist with strong expertise in translational cell models, mechanistic ... complex in vitro/ex vivo assays and mechanistic experimentation to advance early drug discovery projects from target concept through lead optimization. The candidate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …approach. Regulatory and Safety Compliance: Understand study conduct from supply chain/ drug forecasting to safety and regulatory requirements related to ... research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Merck & Co. (North Wales, PA)
- …drug /vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory , Statistical Programming, Data Management, and other company Research ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP) has primary responsibility for the planning and directing clinical research activities involving new or marketed ... drugs for oncology indications. The Associate Vice President will manage and oversee the entire cycle of clinical development, including study design, initiation,… more
- Merck & Co. (Rahway, NJ)
- …assays to help confirm engagement of therapeutic targets and understand mechanisms of drug action and patient response. The Mass Spectrometry group within the TMB ... are deployed in support of clinical trials. The candidate for this Associate Principal Scientist position should have strong technical expertise in Liquid… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted ... activities; collaborates closely with data manager to ensure high quality data. Drug Development Strategy: Provides input to multiple aspects of the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted ... to ensure high quality data. Work closely with internal statistical programmer. Drug Development Strategy: Provides input to multiple aspects of the development… more
- Merck & Co. (Rahway, NJ)
- …trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the ... This includes the ability to:Apply strong knowledge of clinical research regulatory requirements (eg, GCP and ICH)Manage multiple competing priorities with good… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and management to drive strategies and activities for early and late phase drug development candidates within the team to support overall CMC development plan.- ... Represent CMC development project teams on cross-functional drug development project teams with a predominately operational focus; ensuring to establish good working… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director. The team is part of the Global Clinical Development ... organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration.… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director, Alliance Management.Tris Pharma has a long track record of successful ... spanning many departments across all stages of the product lifecycle. The Associate Director, Alliance Management will be accountable for managing alliances of high… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Ophthalmology will focus on driving strategy, development, and ... understanding of the disease area, the functions and processes relevant to drug development, and project management principles as applicable to the pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- …a motivated scientist with technical expertise in Biologics Potency assays in drug Development. More specifically, the ideal candidate will be a recognized expert ... assays for the development of therapeutic proteins, monoclonal antibodies, antibody- drug conjugates, and/or new modality-based products.--The successful candidate is… more
- Insmed Incorporated (San Diego, CA)
- …and Best Medium Workplaces™ lists.OverviewJoin the Technical Operations team as Associate Director of MSAT where you will support pipeline programs that ... process deviation resolution, process improvements and scientific expertise in the Drug Substance and Drug Product. Provides strong technical leadership… more
