- Pfizer (Cambridge, MA)
- …analysis, providing data interpretation, and contributing to clinical publication and regulatory submissions. + Provides statistical input to study designs and can ... collaborate on the reporting of clinical trial results to regulatory authorities and the scientific community by contributing to...of experience in clinical trials. High aptitude in: * FDA /EMA and other regulations * ICH GCP guidelines *… more
- Philips (Cambridge, MA)
- …dissemination of evidence derived from clinical development endeavors, engaging with regulatory bodies and influential stakeholders to shape policy and industry ... ensuring prompt and thorough resolution in accordance with agreed-upon timelines and regulatory requirements. **You're the right fit if:** + You have a minimum… more
- Norstella (Boston, MA)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… more
- Element Materials Technology (Acton, MA)
- **Overview** Join Element's Acton laboratory, a cGMP-certified, FDA - and DEA-registered facility specializing in microbiology, environmental monitoring, and ... pharmaceutical companies in maintaining contamination control, product quality, and regulatory compliance-helping ensure safe, effective therapies reach patients faster.… more
- Sumitomo Pharma (Boston, MA)
- …using SAS + Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc. + Executing Pinnacle ... 21 Checks + Knowledge about CDISC and Regulatory Guidelines + Demonstrate coaching skill to mentor Statistical...to achieve objectives in innovative and efficient ways. + FDA submission experience is a must. + Solid knowledge… more
- Fresenius Medical Center (Lawrence, MA)
- …to ensure accuracy, relevance, and alignment with treatment protocols and regulatory standards. Coordinate with Product Marketing, Value Stream, and the ... products Ensure all materials are reviewed and approved through appropriate regulatory and medical review processes. **PHYSICAL DEMANDS AND WORKING CONDITIONS:** The… more
- Charles River Laboratories (Shrewsbury, MA)
- …inspections of routine processes to assure compliance with applicable GLP regulatory requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Assure Charles River's ... with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling… more
- Takeda Pharmaceuticals (Boston, MA)
- …It collaborates cross-functionally to ensure scientific rigor and compliance with regulatory standards in all decision-making processes. As part of DQS, the ... the cross-functional interfaces with the Statistics function. + Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design,… more
- Hologic (Boston, MA)
- …service delivery for medical device products, driving customer satisfaction, regulatory compliance, and operational excellence throughout the district. **Key ... **Compliance & Safety** + Ensure all service activities comply with company policies, FDA regulations, and relevant standards (ISO, OSHA). + Promote and enforce a… more
- Charles River Laboratories (Shrewsbury, MA)
- …+ Other: Demonstrated analytical and problem solving capabilities. Understanding of regulatory requirements of study types assigned, as well as Testing Facility ... with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling… more