- Sanofi Group (Cambridge, MA)
- …clinical trials, marketing strategies, and key publications. + **Regulatory and Compliance Oversight** : Oversee the medical review and approval of regulatory ... clinical practice. + At least 5 years of progressive experience in the pharmaceutical or biotech industry working in Medical Affairs and/or clinical research and… more
- Takeda Pharmaceuticals (Boston, MA)
- …proposed. + The Sr Director/Director will be accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports ... responsible. + Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. + Leads the GRT and… more
- Integra LifeSciences (Braintree, MA)
- …Process Validation, or other studies as deemed necessary. + Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal ... support development and sustaining/remediation projects. + Maintain all projects are in compliance with GMP, QSR, ISO or other applicable requirements. + Identify… more
- United Therapeutics (Boston, MA)
- …are as follows:** **Who we are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public ... a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.… more
- Sanofi Group (Framingham, MA)
- …on pharmaceutical manufacturing processes + Regulatory Knowledge: Familiarity with pharmaceutical industry regulations, including GMP and FDA standards + ... Performs strategic planning and development activities for site CQ, including compliance , capacity, timeline and direction. + Align department objectives with… more
- AbbVie (Worcester, MA)
- …mostly through lab and/or pilot plant based activities. + Responsible for compliance with all applicable Corporate and Divisional policies and procedures. + ... handling of materials, controlled drug and radioactive compounds, GxP compliance , and animal care where applicable. Qualifications Qualifications + Bachelors… more
- Stantec (Devens, MA)
- …Project Scheduler with 4-5 years of experience in Life Sciences projects ( pharmaceutical , biotech, or related industries). The ideal candidate will have a strong ... environment with cross-functional teams. - Familiarity with GMP regulations, FDA standards, and validation protocols. - Experience supporting capital projects… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …industry organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. ... officials. Ability to evaluate complex issues and meet deadlines to ensure compliance , as well as business timelines to accomplish company objectives. Ability to… more
- Burns & McDonnell (Newton, MA)
- **Description** The Senior Architect - Process will lead in the development of pharmaceutical and life science projects teams to create world-class designs for Life ... effective management of change orders. + Applies knowledge and understanding of FDA , cGMP, and other concepts, practices, codes, and procedures within the industry.… more
- Danaher Corporation (Waltham, MA)
- …and stay aligned with relevant laws and regulations, including healthcare compliance (eg, Anti-Kickback Statute), FDA regulations, anti-corruption (eg, FCPA), ... provides legal guidance on a wide range of commercial, compliance , and regulatory matters, with a particular focus on...law firm and in-house roles in the medical device, pharmaceutical , or life sciences sector. . Strong contract drafting… more