- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Review and interpret regulatory ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads… more
- Merck & Co. (North Wales, PA)
- … Data Repositories.United States and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Tris Pharma (Monmouth Junction, NJ)
- …(FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director/Director, AR&D serves as Deputy ... Associate Director/Director, Analytical Research and DevelopmentMonmouth Junction, NJ...She/he also reviews and approves all scientific, technical and regulatory packages per International Council for Harmonization (ICH)/Food and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, 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 and collecting… more
- Merck & Co. (North Wales, PA)
- …for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory , Statistical Programming, Data Management, and other company ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …The Associate Principal Programmer will write programs to analyze data with statistical methods which are not currently available through commercial software ... Job DescriptionPosition Description: Associate Principal Statistical Programmer - Oncology (Hybrid) In BARDS (Biostatistics and Research Decision Sciences), a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Principal Scientist, Biologics Analytical Research and Development (Onsite) The Biologics Analytical Research & ... of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Kenilworth, New Jersey research… more
- Aequor (Thousand Oaks, CA)
- … requirements, written procedures and safety guidelines Ability to evaluate documentation/ data according to company and regulatory guidelines Ability to ... a weekend (1x/ month this is a rotation) Under general supervision, the QC Associate will perform routine procedures and testing in support of the QC Microbiology… more
- Merck & Co. (Rahway, NJ)
- …products. Our team is looking for a candidate for the position of Associate Principal Scientist (R4) supporting the Biologics formulation team within Sterile Product ... the generation of experimental designs, execution of experimental plans and data analysis Support both early and late-stage development candidates, including… more
- Merck & Co. (Millsboro, DE)
- …Delaware seeks to add an Attending Veterinarian in the role of Associate Director.This position will have overall responsibility for oversight and administration of ... and maintenance of animal facilities. This position is responsible for providing data , documentation, and other information as needed for annual reports to Federal… more
- Aequor (Thousand Oaks, CA)
- …to regulatory guidelines, perform routine lab procedures, and manage data . Flexibility, attention to detail, and strong communication skills are essential, along ... requirements, written procedures and safety guidelines ? Ability to evaluate documentation/ data according to company and regulatory guidelines ? Ability to… more
- Merck & Co. (North Wales, PA)
- … data to support decision making in clinical trials.-The Associate Principal Scientist, Statistical Programmer supports the design, development, and delivery ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Principal Scientist, General Medicine Publications Medical Writing, works with scientists in our company's Research Labs and external ... projects and other of our Research & Development Division science. The Associate Principal Scientist is expected to collaborate with our Research & Development… more
- Merck & Co. (North Wales, PA)
- …covariate dataProduce tables and graphics for inclusion in study reports and regulatory submissionsEnsure programmatic traceability from data source to modeling ... programming analyst will gather and interpret user requirements, retrieve the required data , transform the data into modeling-ready analysis datasets, and… more
- Merck & Co. (Rahway, NJ)
- …drug products.Our team is looking for a candidate for the position of Associate Principal Scientist (R4) supporting the Biologics formulation team within Sterile and ... generation of experimental designs, execution of experimental plans and data analysisSupport both early and late-stage development candidates, including screening… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director, Clinical Scientist This position drives scientific planning, strategy and execution of Phase 1-4 clinical ... trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as we work together to change lives for the better. The Position The Associate Director, Digital Content Strategy & Production reports to the Dir, Content & Channel ... Social Media Marketing and related recommendations for the NNI US website. The Associate Director supports the development and evolution of NNI's content strategy in… more
- Merck & Co. (North Wales, PA)
- Job DescriptionWe are seeking an experienced, strategic, and results-oriented- Associate Director, Partnership Management-to support and drive our internal and ... roles and process, and will maintain the highest level of compliance with regulatory requirements, and applicable laws and regulations. In addition, we are seeking a… more
