- Merck & Co. (Rahway, NJ)
- … product manufacturing processes to GMP production facilities.Experience authoring regulatory filings, and demonstrated working knowledge of FDA, ICH, and other ... Job DescriptionThe Mixed Modalities team within the Sterile Product Development is responsible for developing parenteral dosage forms (injections, implants, inhaled,… more
- Merck & Co. (Durham, NC)
- …meet established delivery timelinesProvide active support during audits and inspections ( regulatory , internal, safety)Collaborate with site compliance team to ... responsibility. IMPACT: InfluenceRepresents Quality in the laboratory to influence cGMP compliance and ensure product quality.Explains difficult issues and… more
- Merck & Co. (Rahway, NJ)
- …software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product development to ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Rahway, NJ)
- …years of leadership experience with deep working knowledge of device, biologic/drug product , and process development including regulatory submission and approval ... Job DescriptionOur company's Device Product & Process Development (DPPD) Team designs, develops,...products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead… more
- Merck & Co. (Rahway, NJ)
- … regulatory documentation. Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across ... and Skills: -The candidate should have a strong track record in biologics product development/ regulatory filing/ drug delivery/ complex formulation and process… 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)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …existing CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/ Regulatory compliance across CMR functions. Position will serve ... execution, maintenance of technical training across all CMR functions, and compliance across clinical development, medical, and regulatory roles/processes/SOPs… more
- Tris Pharma (Monmouth Junction, NJ)
- …materials, activities and related communications and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, ... developing meaningful customer/influencer relationships and ensuring successful and ethical product promotion. She/he is also responsible for leading/managing our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with sales, marketing, medical affairs, market access and policy/advocacy (MAPA), regulatory affairs, and other relevant departments to ensure that educational ... contribute to improved patient outcomes and experiences. Essential Functions Educational Program Strategy : Lead the development of comprehensive strategies to… more
- Aequor (Swiftwater, MN)
- …reagent program , which includes inventory management, international shipping in compliance with Regulatory Affairs. Also support the assay lifecycle ... role are as follows: QC Test Material Management International Shipments new product support compendial compliance method transfers method validation support… more
- Tris Pharma (Monmouth Junction, NJ)
- … compliance guidelines and ensures knowledge of legal and regulatory requirements to appropriately respond to medical inquires, disseminate scientific information ... and report Adverse Events (AEs) and Product Quality Complaints (PQCs)Collaborates with VP/Medical Affairs to ascertain and secure resources and support needed for… 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 ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Technically independent and maintains up-to-date knowledge of industry standards and regulatory compliance requirements and independently contributes to the ... a global supply of our hemophilia and growth hormone product lines, as well as our next generation of...GMED or TGA regulated production facility Knowledge of GMPs, Compliance and Regulatory requirements is essential Excellent… more
- Merck & Co. (North Wales, PA)
- …outcomes, epidemiological studies and economic modeling. -The incumbent contributes to product development and commercial strategies to ensure that the value of ... closely with other colleagues in outcomes research, Franchise Teams, Regional Product Directors, country affiliates, Global Market Access, and Global Medical and… more
- Novo Nordisk Inc. (WA)
- …customers. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing ... as other Market Access & Public Affairs teams, Medical, Legal, Compliance , Communications and other key stakeholders locally and globally. External relationships… more
- Ford Motor Company (Dearborn, MI)
- …the program in assessing and assuring product safety. + Supervise Program Regulatory Compliance and Safety Engineer(s) to deliver all regulatory ... and maintain Compliance Strategy Templates for pre-production programs to support program milestone health chart reviews. + Ensure product content for safety… more
- Applied Materials (Austin, TX)
- …in accordance with predetermined requirements, with specific attention to product /process specifications, project/ program costs, resource utilization, and ... **Key Responsibilities** Ensures that specific project and program objectives are defined for areas of responsibility,...of Applied Materials global Standards of Business Conduct and compliance with these standards at all times. This includes… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …it is likely not legitimate._ **Job Description** The Lead Enterprise Architect ( Product Development & Regulatory Compliance ) is responsible for ... Technology Roadmap *Define a compelling architectural vision for the Product Development & Regulatory Compliance ...coverage effective on start date + 24/7 Employee Assistance Program + Free live and on-demand Wellbeing Programs +… more
- S&P Global (New York, NY)
- …We are seeking an experienced Executive Director of Product Management to lead the Regulatory & Compliance product team. To be successful in this role, a ... cross-functional stakeholders. + ** Product Roadmap** **:** Define and manage the Regulatory & Compliance product roadmap, including prioritization of… more
