- Insmed Incorporated (NJ)
- …and Risk-Evaluation and Mitigation Strategies (REMS).Prepare responses to inquiries from regulatory authorities on safety issues for assigned products and ... lead the integrated safety input into all regulatory documents where required.Maintain and evaluate Medical Safety metrics and quality plan, including… more
- Insmed Incorporated (NJ)
- …role responsible for creating and implementing programs that ensure workplace safety , regulatory compliance, and environmental protection for all Insmed ... employees and consultants for instruction in subjects relating to health and safety and regulatory compliance (laws, regulations, requirements). Ensuring the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Commercial Operations, Commercial, NNI IT and Telephony, Medical Information, Product Safety , Regulatory , Quality, Legal, Privacy and Finance. External ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...capabilities. This position will also manage and oversee Product Safety practices, monitoring and audits across all Patient Support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trials, post-marketing and other relevant sources for the prompt identification of safety signals.Lead internal and external (especially regulatory , but also ... evaluation related documents/deliverables on time.Coordinate and participate actively in safety -related regulatory interactions (eg, regulatory meetings,… more
- Bayer (Urbandale, IA)
- …DSO principles; Healthcare sales experience focused on MRI technology, contrast agents, and regulatory & safety standards or industry experience in MR imaging ... more years of experience focused on MRI technology, contrast agents, and regulatory & safety standards or industry experience in MR imaging suites (eg, HCP,… more
- Bayer (San Francisco, CA)
- …DSO principles; Healthcare sales experience focused on MRI technology, contrast agents, and regulatory & safety standards or industry experience in MR imaging ... more years of experience focused on MRI technology, contrast agents, and regulatory & safety standards or industry experience in MR imaging suites (eg, HCP,… more
- Bayer (Chicago, IL)
- …DSO principles; Healthcare sales experience focused on MRI technology, contrast agents, and regulatory & safety standards or industry experience in MR imaging ... more years of experience focused on MRI technology, contrast agents, and regulatory & safety standards or industry experience in MR imaging suites (eg, HCP,… more
- Merck & Co. (Millsboro, DE)
- …Operations Management, Process Improvements, Process Manufacturing, Product Handling, Recordkeeping, Regulatory Compliance, Safety Practices, Safety ... people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Support the optimization and efficient utilization of the warehouse space.Assist in regulatory inspections, perform safety and quality audits, and answer ... and work instructions and comply with cGMP regulations and safety guidelines.Establish key stakeholder relationships with internal and external stakeholders.… more
- Merck & Co. (South San Francisco, CA)
- … safety /compliance). Prepare and contribute PET-specific scientific content for regulatory filings, including IND submissions. Partner and site management : ... Oncology Trials, Positron Emission Tomography (PET), Project Leadership, Radiation Safety , Radiopharmaceuticals, Radiopharmacy, Regulatory Compliance, Regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …campus infrastructure, equipment, and systems support business goals and comply with safety , regulatory , and sustainability standards. This position is a key ... commissioning / qualification professionals.Ensure compliance with all applicable health, safety , environmental, and building regulations (OSHA, ADA, EPA, etc.).Establish… more
- Aequor (Thousand Oaks, CA)
- …The role requires adherence to current Good Manufacturing Practices (cGMP), safety guidelines, and regulatory requirements while supporting analytical testing, ... principles is preferred but not required Preferred Qualifications Ability to follow regulatory requirements, written procedures, and safety guidelines Ability to… more
- Bayer (Filer, ID)
- …to ensure an efficient greenhouse (GH) production operation that is compliant with safety , plant health, quality and regulatory requirements. YOUR TASKS AND ... seed inventory. Ensures that GH operations are fully compliant with safety , quality and regulatory requirements to maintain our Freedom to Operate; Develop and… more
- Cipla (Hauppauge, NY)
- …effectively and clearly, both written and verbally in English. Comply with safety and quality regulatory standards when packaging products.Ensure products are ... (SOI) and Logbook. Determine when to stop a line related to safety or quality. Operate automatic packaging equipment. Document packaging activities. Feed filling… more
- Cipla (Hauppauge, NY)
- …Validation Engineeris toensure that products, equipment, and systems meet all applicable safety , quality, and regulatory requirements. They do this by developing ... Part 11 compliance. Demonstrated ability to interpret and apply pharmaceutical industry regulatory compliance requirements with an emphasis on US and EU/MHRA data… more
- Tris Pharma (Monmouth Junction, NJ)
- …maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety , quality, and regulatory standards in warehouse operationsManages, ... and assurance of compliance with GxP and other company and regulatory agency procurement policies and procedures throughout the organization. Ensures compliance… more
- Merck & Co. (Durham, NC)
- …change requests. Acts as a participant in domestic and international regulatory agency inspectionsSupporting all quality and safety initiativesProvide technical ... diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety , Process Development, Technical Services, Utilities and Validation. -At… more
- Merck & Co. (Durham, NC)
- …Sustainability portfolio in its entirety involving any of the following: Regulatory compliance with internal interpretations Manage project strategy for the Durham ... department systems, procedures and ways of working with a focus on safety , current Good Manufacturing Practices (cGMP) compliance and efficiency. Define requirements… more
- Merck & Co. (Durham, NC)
- …support and training to mechanics and other maintenance personnel.Interface with safety , production, and quality groups to ensure facility operations and systems ... systems, procedures and ways of working with a focus on safety , current Good Manufacturing Practices (cGMP) compliance and efficiency.Define requirements and… more
- LabCorp (Shelton, CT)
- …and sign-out of Gastrointestinal pathology specimens. Assure compliance with quality, regulatory , and safety guidelines/standards Accurate and timely evaluation ... good laboratory practice (GLP) and compliance with applicable accrediting and regulatory agencies Provide expert consultation as needed with clients and staff,… more
