- Cook Medical (Winston Salem, NC)
- …CO-OPs* Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements* Must maintain ... all training requirements for the position, while seeking out opportunities for continuous development and growth Qualifications * College/University student entering Sophomore, Junior or Senior year the following Fall Semester or Graduate student enrolled in… more
- Amgen (Holly Springs, NC)
- …and International Conference on Harmonization (ICH) / Food & Drug Administration ( FDA ) mentorship documents related to analytical method transfer and validation. + ... Effective oral and verbal communication skills. + Technical writing skills and attention to details in documents. + A self-starter and valuable teammate. **What you can expect of us** As we work to develop treatments that take care of others, we also work to… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Strong understanding of CGMP/GLP and related regulatory health authority guidance ( FDA regulations, ICH guidelines, etc.) as they relate to the pharmaceutical ... industry. Must be proactive, results-oriented with a strong attention to detail and strong time management skills. Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced critical work environment. Ability to… more
- Merck (Raleigh, NC)
- …and focus on scientific education and dialogue + A thorough understanding of FDA , OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant to the ... pharmaceutical industry and its customers to ensure compliance with all external and internal guidelines and standard operating procedures + Ability to organize, prioritize, and work effectively in a constantly changing environment and to motivate a team to do… more
- Parexel (Raleigh, NC)
- …applicable. + Ensure document structure, content, and style adheres to FDA /EMA or other appropriate regulatory guidelines, and comply with departmental, corporate ... or client SOPs and style guidelines, as applicable. + Provide suggested alternative content when contributors provide content that does not meet document needs. + Provide medical editing review of draft and final documents prepared by other writers before… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …by following standard operating procedures and batch records in accordance with FDA current Good Manufacturing Practices. In addition, personnel in this position ... will employ above average mechanical aptitude and acceptable aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Personnel in this position will provide support in inspection and packaging… more
- Mentor Technical Group (NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …year pharmaceutical, chemical, and/or production manufacturing experience in a regulated industry ( FDA , USDA, NRC) obtained within the last 5 years (completion of ... the "Bioworks Certification Program" through a community college a plus) or + Graduation from an accredited college/university with an Associate's or Bachelor's degree in: Biology, Chemistry, Biochemistry, Engineering, Pharmaceutical Technology, Business,… more
- Edwards Lifesciences (Raleigh, NC)
- …R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA , ISO) for pharma/medical devices + Excellent problem-solving, analytical, and critical ... thinking skills + Proven leadership and ability to influence change + Skilled in training/coaching and facilitating organizational change + Detail-oriented; able to manage competing priorities in fast-paced environments + Professional interaction across all… more
- Edwards Lifesciences (Raleigh, NC)
- …and performance oversight. + Expertise in medical writing processes, regulatory requirements ( FDA , EU MDR), GCP, and ICH guidelines. + Advanced knowledge of ... biomedical statistics, clinical literature review, and therapeutic/product operations. + Skilled in Microsoft Office Suite and publication/database tools (EndNote, Medline, PubMed). + Exceptional problem-solving, analytical, and communication skills; ability… more