- Merck (Boston, MA)
- …inquiries and adverse reports in accordance with internal, FDA, CFIA and USDA regulatory policies. The successful candidate for this position will be required to ... Support, Livestock Management, Nutritional Medicine, Nutritional Science, Project Management, Regulatory Policies, Strategic Planning, Teamwork, Veterinary Medicine, Veterinary Pathology… more
- ThermoFisher Scientific (Boston, MA)
- …ensure accuracy and completeness of information presented in analytical documents and regulatory filings. Assist with comment resolution if needed + Support internal ... perform the job **(comparable to 2+ years')** + OR ** PhD ** In some cases, an equivalency, consisting of a...and investigation + In-depth knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept +… more
- Bristol Myers Squibb (Cambridge, MA)
- …Participates in post-hoc biomarker analysis and publication efforts + Supports regulatory submissions and regulatory interactions as needed **Skills/Knowledge ... Required** + 7+ years of late stage clinical biomarker experience in industry (biotech/pharma) + Recognized expertise in translational biomarkers in neurology space + Experience in late stage drug development and activities required for and related to clinical… more
- Lilly (Boston, MA)
- …Collaborate cross-functionally with internal stakeholders (medical, operations, statistics, regulatory ) and external partners (CROs, academic institutions) to ensure ... discussions, reinforcing Lilly's leadership in biomarker innovation. **Basic Qualifications:** + PhD in Neuroscience, Biochemistry or a related field, with 8+ years… more
- Sanofi Group (Framingham, MA)
- …facility fit assessments, and process validation activities at CMOs. + Support regulatory filings and inspections for the processes manufactured at CMOs. + Manage ... 9 years, or Master's degree with 7 years, or PhD with 5 years in industrially relevant biologics development,...and process control strategy establishment + Experience with authoring regulatory filings and supporting PAI and other health authority… more
- IQVIA (Boston, MA)
- …of client strategy and objectives. + Review technical documents to ensure regulatory compliance in all content created. + Identifies, develops, recommends and/or ... for inclusion as a resource for content development. + Reviews clinical regulatory documents and communications. + Understands trends in the scientific communication… more
- Sanofi Group (Cambridge, MA)
- …Our Medical function serves as a key strategic partner with commercial, regulatory , clinical, and market access on therapeutic solutions to support patients' needs. ... You** **Education:** Advanced degree in a scientific discipline (MD, PhD or PharmD) **Experience:** + Significant immunology experience required (Gastroenterology… more
- Sanofi Group (Cambridge, MA)
- …medical science, clinical trials, marketing strategies, and key publications. + ** Regulatory and Compliance Oversight** : Oversee the medical review and approval ... of regulatory documents, ensuring adherence to company standards and government/industry...degree from an accredited college or university (eg, MD, PhD , PharmD, or equivalent) with experience in a medical… more
- Takeda Pharmaceuticals (Boston, MA)
- …development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency ... leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds. +… more
- Sanofi Group (Cambridge, MA)
- …compliance with all corporate and industry policies and legal and regulatory requirements, for all medical affairs activities + Ensure promotional/non-promotional ... include major assets, sound medical advice that minimizes the risk of regulatory and legal action, competitively positions assigned products and is consistent with… more