- Catalent Pharma Solutions (Chelsea, MA)
- …and quality specialists; + Demonstrate knowledge of International Quality and Compliance standards and requirements, with preferable FDA experience; + ... a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer,...member of the site leadership team ensure an effective Pharmaceutical Quality Management system is in place, adequately resourced… more
- Takeda Pharmaceuticals (Boston, MA)
- …lifecycle + Subject matter expert on EFPIA, IFPMA, and FDA code/regs, guidance, industry standards, complaints/violations, and innovative promotional platforms ... Regulatory Subject Matter Expert: Provide expertise on EFPIA, IFPMA, and FDA codes, regulations, guidance, industry standards, and innovative promotional platforms.… more
- System One (Devens, MA)
- …of GMP requirements + Maintain accurate documentation of all production processes in compliance with FDA cGMPs, DEA regulations, and company SOPs + Partner ... 7% annual bonus Type: Direct Hire Overview Our client, a leading API pharmaceutical manufacturer, is seeking two Production Leads to join their expanding Devens, MA… more
- Sanofi Group (Cambridge, MA)
- …well as contracting. Candidates should have experience advising global pharmaceutical companies on marketing, distribution, promotion, scientific exchange, and ... counsel concerning a broad range of legal issues, including, interpretation of FDA and other regulations, including the False Claims Act, Anti-Kickback Statute and… more
- Boehringer Ingelheim (Boston, MA)
- …relationships with co-investors, academic institutions, and tech transfer offices. + ** Compliance & Governance:** + Ensure adherence to global governance standards, ... pharmaceutical regulations, and ethical guidelines in all investment activities....Company business in accordance with all regulations (eg EEO, FDA , OSHA, PDMA, EPA, PhRMA, etc.) and Company policies… more
- Cardinal Health (Boston, MA)
- …hospitals, physician offices, etc.), strategic sourcing, marketing, regulatory/ compliance and contract manufacturing. **_Responsibilities_** + Demonstrate strong ... + Handle fast paced and high-volume workload + Identify legal and compliance issues and business risks and escalate appropriately + Effectively communicate with… more
- Merck (Boston, MA)
- …Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance , Leadership, Motivation Management, Pharmaceutical Regulatory ... with global regulatory authorities to ensure successful registration and compliance . Global Immunology submission experience in IBD strongly preferred. **Primary… more
- Integra LifeSciences (Braintree, MA)
- …quality systems, and a commitment to ensuring product safety and compliance . The ideal candidate should demonstrate proficient experience with quality management ... improvement **SUPERVISION RECEIVED** Under direct supervision of Sr. Quality Compliance Manager, Environmental Controls. **SUPERVISION EXERCISED** Indirect supervision of… more
- Sumitomo Pharma (Boston, MA)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... preferred. + Minimum 3 years' experience within Pharmacovigilance and in the pharmaceutical industry. + Prior experience in oncology, and/or neurology is strongly… more
- Chiesi (Boston, MA)
- …ecosystems. + Direct global early access and compassionate use programs, ensuring compliance with varied regulatory frameworks (eg, FDA , EMA, and other ... care and consumer-facing self-care). We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social… more