- Merck (North Wales, PA)
- **Job Description** **Position Description:** **Legal Director ( FDA promotion/Labeling Drugs & Vaccines)** The position provides legal support to the Human Health ... a focus on counseling clients in the areas of FDA promotion and labeling of drugs and vaccines. The...responsibility include, but are not limited to: + Food, Drug , and Cosmetics Act compliance + Advertising and promotion… more
- Lilly (New York, NY)
- …documents to ensure appropriate data capture and quality for analysis. + Ensure regulatory compliance of statistical analyses with SOPs, FDA /EMA and ICH ... **Position Summary** We are seeking an experienced and highly motivated Advisor (Senior Manager)/Senior Advisor (Associate Director) Clinical Biostatistics to… more
- Lilly (Philadelphia, PA)
- …This position will provide technical expertise and leadership to support Avid's drug development program. The Advisor /Technical Lead is responsible for providing ... within the Analytical Development and Quality Control group in support of Avid's drug development program. The individual is expected to participate on project teams… more
- Lilly (Indianapolis, IN)
- …In response to a rapidly growing portfolio of projects, DDCS is seeking an Advisor - Engineering within the Packaging Systems team. You will be an individual ... motivated individual with the ability to impact the following areas: ** Drug Discovery, Development, and Commercialization** + Think critically, guide the design,… more
- Lilly (Indianapolis, IN)
- …and line extensions across multiple geographies. This may involve direct interaction with FDA , EMA, PMDA and other regulatory agencies. + Provide coaching and ... throughout the value chain from preclinical lead molecule identification to clinical post- drug approval. We work with the goal of identifying and developing the… more
- Merck (Rahway, NJ)
- …meetings between our Company and FDA ; prepares the teams for meetings with FDA at all phases of drug development. + Leads cross-functional efforts to prepare ... **Job Description** The Director, Regulatory Affairs Liaison, is responsible for development and...marketed products throughout the entire life cycle of the drug . + Provides leadership to the staff by leading… more
- IQVIA (Durham, NC)
- …**Job Overview** Provide leadership and advice on the development of optimum regulatory strategies for drug development, product lifecycle management and ... conferences and webinars, as appropriate. **Essential Functions** + Integrate strategic regulatory & drug development support services into emerging… more
- Merck (Rahway, NJ)
- …Laboratory Practice (GLP) regulations and regulations on electronic records + Knowledge of US- FDA and EU-CVMP guidelines on veterinary drug development for food ... and in the preparation of study documents for submission to regulatory agencies + Excellent verbal communication and presentation skills required; required… more
- Merck (Rahway, NJ)
- …economic modeling) with ability to understand how MIDD can drive portfolio and regulatory decisions. + Deep knowledge of drug development, pharmacokinetics and ... Biopharmaceuticals, Chemical Engineering, Clinical Medicine, Clinical Trial Designs, Computational Biology, Drug Development, Drug Discovery Process, FDA … more
- Merck (Columbus, OH)
- …by key authorities such as the United States of America Food and Drug Administration ( FDA ), European Medicines Agency (EMA), UK Medicines and Healthcare ... to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new...Contact (POC) for a specific area of regulations (eg FDA , EMA, NMPA, etc.). As such, the CQOM is… more
- Editas Medicine (Cambridge, MA)
- …the treatment of serious genetic diseases. This individual will serve as a scientific advisor and lead teams of scientists in the design of project strategies and ... acid-based, or gene therapy products; and possess a solid understanding of FDA /EMA guidelines. This individual will be collaborative, with proven ability to manage… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …of the Amneal Legal team, and will serve as a trusted legal advisor for all commercial activities involving the company's specialty, biosimilar and generic products. ... that materials and strategies are compliant with legal and regulatory requirements as well as with internal company policies....reports. Advise on REMS operations, prescriber disputes, industry and FDA developments. Stay current on FDA regs.… more
- Pfizer (New Haven, CT)
- …of it in clinical trials. **Preferred Qualifications** + Knowledge of local and international drug development regulations ( FDA , EMA) and process is an asset. + ... to the Clinical Services Director, Business Operations Director, Pharmacy and Regulatory Directors, Medical and Scientific Advisor , and Safety Laboratory… more
- Merck (Rahway, NJ)
- …and drug product. Collaborates with partner groups (operations, quality, regulatory , etc) to ensure file/launch on time. Drives development and delivery of ... for collective success, including quality, operations, engineering, supply chain, regulatory /CMC, commercial, and other manufacturing network sites. **Job Responsibilities:**… more
- Veterans Affairs, Veterans Health Administration (Martinez, CA)
- …and Health Administration (OSHA), Environmental Protection Agency (EPA), Food and Drug Administration ( FDA ), etc.) and other applicable requirements. Researches ... Management, and Oversight; Healthcare Facility Engineering Program Administration; Healthcare Regulatory , Safety, and Accreditation Compliance; Strategic Planning; Technical Personnel… more
- Merck (Columbus, OH)
- …for bioanalytical outsourcing. Oversight will include Pharmacokinetics (PK), Anti- Drug Antibody (ADA), and Neutralizing antibody (Nab) assays. Job responsibilities ... and achieve company quality expectations. + Maintains a contemporary knowledge of Regulatory and GLP requirements and ensures externally supported work is following… more
- Charles River Laboratories (Houston, TX)
- …worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ... monitor the preventive health program appropriate to the site's needs. * Serve as advisor to management in technical matters as they relate to the site including… more
- Charles River Laboratories (Reno, NV)
- …worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ... suppliers. Monitor a Biosecurity program appropriate to site needs. * Serve as advisor to management in technical matters as they relate to the site including… more
- Veterans Affairs, Veterans Health Administration (Manchester, NH)
- …of the environment of care program that meets current Joint Commission, Food and Drug Administration ( FDA ), College of American Pathologists (CAP), NFPA, and VA ... and others. The position serves as a healthcare engineering advisor , engineer consultant, engineer designer, contract administrator, project manager, construction… more
- Amgen (Thousand Oaks, CA)
- …Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements + Understanding of new drug commercialization and ... mobilizing the team to execute against it + Serve as a senior advisor or executive sponsor for functional, cross-functional and/or corporate initiatives + Critically… more