- Charles River Laboratories (Shrewsbury, MA)
- …proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal ... Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you are interested in applying to… more
- Merck (Boston, MA)
- …management, communication, and networking skills + A thorough comprehension of FDA , OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant ... to the pharmaceutical industry and its customers + Ability to organize, prioritize, and work effectively in a constantly changing environment + Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Teams, OneNote) + Familiarity with… more
- Fujifilm (Boston, MA)
- …+ 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. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** + BA/BS required. Biological science or… more
- ZOLL Medical Corporation (Boston, MA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the US At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.ZOLL has been… more
- Actalent (Cambridge, MA)
- …development a plus * Ideally experienced in filing and managing INDs to FDA * Working knowledge of drug development process and US regulatory requirements required; ... knowledge of EU, Canada, ROW, and post-marketing regulatory requirements a plus Pay and Benefits The pay range for this position is $75.00 - $75.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …**Qualifications** + Bachelor's degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment + Strong knowledge of ... current global Good Clinical Practice (GCP) for designing, recording and reporting trials that involve the participation of human subjects. Managing compliance with this standard to provide assurance that the rights, safety and wellbeing of trial subjects are… more
- Cambrex High Point (Waltham, MA)
- …working knowledge of GMP requirements, ICH guidelines, and regulatory expectations ( FDA , EMA). + Experience in quality control testing, stability programs, ... outsourced testing management, and cross-site collaboration preferred. + Peptide and/or oligonucleotide analytical experience is a plus but not required. + Demonstrated ability to work with urgency while maintaining accuracy and compliance. + Strong… more
- RTX Corporation (Andover, MA)
- …Material Program Plan (MPP), Material Contract Brief (MCB), Flowdown Attachment ( FDA ), obtaining Special Burden Material approval and baselining activities. + ... Support FMS & DCS bottoms-up proposal management, including PMER kick-offs, and engaging with the LADS Central Procurement Team to support the capture plan and management of GSC proposal content. + Supports Program audits (internal and external), including USG… more
- Fujifilm (Boston, MA)
- …+ 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:** Lead technical professional experienced in designing, implementing, documenting, and executing complex technical projects. A person in this position is expected to possess an expert level… more
- Cardinal Health (Peabody, MA)
- …+ Responsible for Cardinal Health compliance and regulations concerning OSHA, DEA, FDA , State and local authorities; primary facility contact for QRA compliance and ... initiatives **_Qualifications_** + High school diploma or GED ; Bachelor's degree preferred + 1-2 years related experience + Working knowledge of Six Sigma process improvement preferred + Strong communication skills + Leadership skills + Basic knowledge of… more