- Merck & Co. (North Wales, PA)
- …and medical teams to ensure that promotional practices are consistent with regulatory guidelines, our company's policies, and support business objectives.Serve ... standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to ensure support for anticipated promotional… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... lead in project teams.Lead, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Late Development Statistics.Lead the… more
- Merck & Co. (Rahway, NJ)
- …and Skills: -The candidate should have a strong track record in biologics product development/ regulatory filing/ drug delivery/ complex formulation and process ... strong candidate for the position of Principal Scientist (R5) within the Biologics product development group. Primary duties: Be a seasoned biologics product … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and challenging legal environment by independently providing innovative and strategic legal support and solutions as a brand attorney and the primary legal advisor ... but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... & parenteral drug products for biologics as well as the biopharmaceutics support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... experience. Responsibilities :Develops, coordinates, and provides biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics.Interacts… more
- Novo Nordisk Inc. (WA)
- … strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position is responsible for independently providing innovative and strategic legal support and solutions as a market access attorney and the primary legal ... to, areas of GPO/PBM and trade/distribution agreements, Medicare, Medicaid, product pricing, and government price reporting. Coordination with, and appropriate… more
- Novo Nordisk Inc. (Atlanta, GA)
- … strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...external customers to further scientific exchange. S/he provides advanced product and scientific and medical field support … more
- Merck & Co. (Washington, DC)
- …device, or related policy background preferred with specific emphasis on above product policy issues-Ability to master complex policy, regulatory and legislative ... Development The Director, Policy Development serves as the leading expert on above- product public policy issues and geo-political changes that will impact our global… more
- Merck & Co. (Rahway, NJ)
- …development and GMP clinical supply manufacture of our Company's drug product pipeline.- The FLEx Process Engineering Lead drives process development expertise, ... the research and manufacturing divisions in the development of formulations in support of oral and combination products using the talent, capabilities, and… more
- Eisai, Inc (Charlotte, NC)
- …in a dialogue about clinical evidence, approved indication(s), and the product efficacy/safety profile to support on-label prescribing for appropriate ... the midst of an approved launch of a new product in the US focused on educating HCPs on...part of a diverse team of sales professionals who support this important launch and will be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Provides oversight to the CRO MM for clinical data review activities- May support addressing eligibility and medical questions from sites/ IRBs- May provide medical ... individual protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction with ... (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions from sites/ IRBsMay provide medical… more
- Merck & Co. (Rahway, NJ)
- …policy development activities to mitigate risk and leverage opportunities in support of our company's business priorities.Reporting to the Associate Vice President, ... across -Global Public Policy (GPP) and the broader enterprise on above product policy and political issues, working closely with the Executive Director, Global… more
- Merck & Co. (Durham, NC)
- …Maintenance Technician is responsible for providing equipment troubleshooting and maintenance support for a new product feasibility - project/manufacturing - ... supporting: - Process Equipment (eg tanks/bioreactors, filtration skids, chromatography columns)- Support Equipment (eg washers, autoclaves, tube - welders/sealers, WFI… more
- Merck & Co. (Rahway, NJ)
- …scientist with an outstanding scientific track-record and passion for pharmaceutical product development. -This individual will use innovative approaches to ... support both early and late stage development candidates including...design, and development of formulations defined by robust drug product compositions and processes. Other responsibilities include statistical experimental… more
- Merck & Co. (North Wales, PA)
- …development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international ... or marketed vaccines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerationsPlanning clinical… more
- Merck & Co. (Durham, NC)
- …Technician is responsible for providing equipment troubleshooting, calibration, and maintenance support for a new product feasibility project/manufacturing ... supporting:- Process Equipment (eg tanks/bioreactors, filtration skids, chromatography columns)- Support Equipment (eg washers, autoclaves, tube welders/sealers)- Automated Systems… more
- Merck & Co. (Durham, NC)
- …and products. Author, review, and/or edit procedures and technical documents to support regulatory filings including standard operating procedures, job aides, ... and contribute to and implement process improvements.This position will support either Fermentation, Purification, Alum Adjuvant, or Sterile Supply production.… more
