- J&J Family of Companies (Wilson, NC)
- …Computer System Validation in a cGMP pharmaceutical facility in compliance with FDA regulations. + Knowledge of Automation Control Systems, Manufacturing & IT ... Systems, and methodologies including GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11 + Good communication & organizational skills when working within multi-functional teams, demonstration task ownership + Knowledge of the SDLC. + Support… more
- Chiesi (Cary, NC)
- …newly created position will initially focus on pre-launch preparation in anticipation of FDA approval of our global market leading product, Trimbow(R). We want to ... find an experienced marketer with the skills, experience, and passion to help us fulfill our mission of helping to introduce Chiesi and our products to the US asthma and COPD respiratory community. This position will guide key commercial projects to engage… more
- Cardinal Health (Raleigh, NC)
- …False Claims Act, Civil Monetary Penalties Law, Stark, Beneficiary Inducement Statutes), FDA regulation (Food, Drug & Cosmetic Act), and privacy (HIPAA). * Draft, ... negotiate and review a wide range of agreements, including complex matters relating to manufacturer supply agreements and co-marketing arrangements. * Advise and ensure that internal clients receive sound, practical and timely legal advice on a wide variety of… more
- ThermoFisher Scientific (Greenville, NC)
- …improvements and efficiencies. + Coordinate regulatory inspections performed by the FDA , MCA, and other agencies. + Defend policies, procedures, rationales, and ... methods during regulatory and client audits. + Establish and supervise quality programs and plans, such as validation, QAT, and supplier certification. **Qualifications:** + High School Diploma or equivalent experience required. + Bachelor's degree in… more
- Compass Group, North America (Charlotte, NC)
- …wellness related programs and initiatives and to ensure compliance with FDA nutrition labeling laws. **Key Responsibilities:** + Coordinates and implements sector ... specific nutrition and wellness programs and initiatives. + Participates in account retention and sales efforts as well as quarterly business reviews. + Develops and presents materials for wellness programs including health fairs, lunch and learns, program… more
- Cardinal Health (Raleigh, NC)
- …investigators participating in ongoing studies + Maintain current knowledge of FDA regulations and internal policies regarding Medical Drug Information, including ... any MSL presentations and Medical/Safety Review Committees + Provides pharmacovigilance support through collaboration with other internal stakeholders by collecting adverse event information, facilitating investigations of safety events, and identifying… more
- Compass Group, North America (Charlotte, NC)
- …* Support educational nutrition campaigns * Executing operational standards * Managing FDA regulation standards * Market Research * Manage website and social ... networking profile content **Learning Objectives** : * Demonstrate awareness, understanding and skills necessary to work in a diverse environment. * Experience opportunities to learn, observe, and practice a variety of nutrition and well-being experiences in… more
- Kedplasma (Greenville, NC)
- …Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... your job description as complete as possible. However, that in no way states or implies that these duties/responsibilities are the only duties you will be required to perform. The omission of specific duties/responsibilities does not exclude them from the… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. **Qualifications** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill, and/or… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …Agile delivery experience + Track record working in a fast paced, FDA regulated IT environment + Experience managing consultants and providing technical ... recommendations + Ability to work independently and manage multiple projects & priorities + Excellent written and verbal communication skills The salary range for this position is: Bay Area: $146,540.00 - $189,640.00. Raleigh: $126,565.00 - $163,790.00. Gilead… more