- Insmed Incorporated (Boston, MA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... mission to transform the lives of patients. They must possess a high clinical aptitude and experience in portfolio selling environment to engage key customers. Along… more
- Merck (Boston, MA)
- …our existing and pipeline products to produce safe, effective, innovative medicine. The Global Clinical Data Standards Vocabulary Specialist, Associate ... Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical...Vocabulary Specialist may lead or participate in:** + Internal clinical data standards forums +… more
- Novo Nordisk (Lexington, MA)
- …journey? The Position This role will provide leadership and guidance to the Global Clinical Organization before, during and after inspections, working with ... vendor assessments and trying to impact external clinical requirements and sharing clinical Quality and GCP knowledge to the global organisation. We also… more
- GE HealthCare (Boston, MA)
- …and support in the assessment and promotion of compliance within all PDx departments including global clinical , non clinical and R&D. This role will be aware ... This role will have a focus on auditing and Global Compliance support to R&D & GCP activities but...clinical trial activities to ensure they meet GCP standards and contractual obligations. + Collaboration and Communication: QA… more
- Edwards Lifesciences (Boston, MA)
- …. **How you will make an impact:** + Design, create, validate, and modify clinical databases, and tools and programs for data validation checks, and ... in the design and delivery of moderately complex functional modules and provide data management expertise regarding clinical trials, protocols, and case report… more
- ConvaTec (Lexington, MA)
- …of clinical studies across Convatec's Business Units. Reporting to Head Global Clinical Operations, this role is key representative for Study Management ... to project timelines and budget; report metrics to Head Global Clinical Operations as required. + Analyze...+ Work closely with other functional groups within Convatec's Clinical Operations team such as Data Analytics,… more
- Boehringer Ingelheim (Boston, MA)
- …acumen, Analytical skills, Learning and Adaptability * Demonstrated experience interpreting clinical data . * Displays AAI behaviors: Agility, Accountability, and ... and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering… more
- Merck (Boston, MA)
- Job Description **Join our team as a Clinical Quality Operations Lead - Inspection Strategy** and be at the forefront of developing and implementing policies, ... with other functions within and outside of GCTO to ensure that Good Clinical Practice Health Authority inspections are adequately supported and managed and that QCO… more
- STERIS (Jamaica Plain, MA)
- Clinical Educator I Req ID: 42465 Job Category: Clinical Support, Operations & Education Jamaica Plain, MA, US, 02130 Description: At STERIS, we help our ... to discuss you joining our industry-leading team as a Clinical Educator. No two people learn the same way,...Document and review training efforts for compliance with industry standards and regulations + Identify employee knowledge gaps at… more
- Randstad US (Lexington, MA)
- …+ Clinical Trial Reports + Pharmacokinetics + Pharmacodynamics + Data presentation + Pharmaceutical Publications + Global Pharmaceutical + Publications ... global pharmaceutical publications consultant. + lexington , massachusetts...Publications, Evidence Generation). + Experience with a variety of data types and outputs, including clinical trial… more
- Takeda Pharmaceuticals (Boston, MA)
- …awareness and the ability to adapt to the needs of the business in a global setting. Solid understanding of the clinical trial process, including GCP, legal and ... of my knowledge. **Job Description** **About the role:** The Global Category Manager - Post Approval is accountable for...of the R&D Procurement team, you will report to Clinical Development Business Partner Lead. **How you will contribute:**… more
- Olympus Corporation of the Americas (Westborough, MA)
- …comprehensive expertise in the interpretation and application of FDA regulations and other global regulations & standards governing CGMPs. + Proven experience in ... developing and implementing efficient, harmonized quality processes compliant with global regulatory requirements. In working with regional (Americas, EMEA, Japan,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …values by staying **True to Life.** **Job Description** The Sr. L&D Specialist, Global QMS Training will serve as a senior individual contributor within Quality. ... This individual will support the management of the global training process, lead strategic training projects, and collaborate with global process owners and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Create and own database build SOPs and processes. The EDC Engineer will work with Data Management and Standards teams to implement new processes as well as ... with leaders to resolve issues affecting the delivery of clinical trials + Collaborate with standards team...development process. + Minimum of 10+ years' experience in Data Management, Programming, Clinical IT, or other… more
- Olympus Corporation of the Americas (Westborough, MA)
- …core values by staying **True to Life.** **Job Description** As a Senior Global Product Manager, Digital Unit for our Healthcare Product - Medical Procedural ... + International Healthcare Experience: Knowledge of international healthcare systems, standards , and regulations + Experience in Quality Management Systems (QMS)… more
- Envista Holdings Corporation (Boston, MA)
- …'Go To Market' Omnichannel approach (incl enabling B2B, B2C, DTC etc.); Consumer Data Acquisition & Offer Management; PIM / DAM & Brand; Website Consolidation & ... Management. We are looking for a Global Head of IT Digital & Commercial Platforms to...commercial platforms and ensure compliance with the policies and standards + Monitor and evaluate digital performance and outcomes,… more
- Novo Nordisk (Lexington, MA)
- … submissions and authorities while ensuring that the process lives up to global standards , regulations and business ethics. The Real-World Science Department is ... + Working with legal and compliance in the context of RWD and/or clinical data + Project management across diverse areas of an organization that required change… more
- Sanofi Group (Waltham, MA)
- … Quality indicators to bolster data integrity and usability. Compliance with Data Standards : + Lead the implementation and monitoring of business policies ... methods, ) within their area, ensuring adherence to Sanofi's data standards . Digital & Data ...+ Strong knowledge of biopharmaceutical R&D data , data domain across Research, CMC, Clinical , Regulatory… more
- Sanofi Group (Waltham, MA)
- … Quality indicators to bolster data integrity and usability. Compliance with Data Standards : Lead the implementation and monitoring of best practices and ... methods, ) within their area, ensuring adherence to Sanofi's data standards . Digital & Data ...of biopharmaceutical R&D domain and metadata across Research, CMC, Clinical , Regulatory + Solid understanding of data … more
- Takeda Pharmaceuticals (Boston, MA)
- … data for research innovation, decision-making, and insights generation. + Define data governance framework, polices, and standards to ensure data ... in ontology-guided data integration. + Comprehensive experience with diverse data types including clinical , genomics, trial manufacturing, instruments, and… more
