- BeOne Medicines (Emeryville, CA)
- …worldwide, Commercial Supply Chain, CMO Project Managers, Alliance Managers, Quality and CMC Development partners to ensure supply continuity with optimal cost and ... requested. - Partner with key global stakeholders from Supply Chain, Packaging, CMC manufacturing and Quality on CMO supplier selection, negotiation and management.… more
- CSL Behring (King Of Prussia, PA)
- …Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate inputs into risk ... maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . + Proactively fosters and promotes effective relationships across Global… more
- Lundbeck (Deerfield, IL)
- …an effective regulatory affairs cross-functional team on a dotted-line basis ( CMC , Regulatory Operations, US Labeling, Promotion Compliance & Scientific Messaging, ... and International regulatory). REQUIRED EDUCATION, EXPERIENCE AND SKILLS: + Accredited bachelor's degree + 10+ years R&D experience within a pharmaceutical and/or biotech industry, with 7+ years' experience in Regulatory Affairs + Experience with supporting… more
- Parexel (Sacramento, CA)
- …be a 40-hour-per-week position. **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with ... qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet… more
- BeOne Medicines (Emeryville, CA)
- …with senior stakeholders and cross-functional teams (clinical, medical, safety, CMC , commercial) across regions to achieve strategic business goals through ... knowledge sharing and collaboration. + Liaise and negotiate with cross-functional teams and regulatory authorities to expedite submission timelines and resolve key regulatory issues in all relevant markets. + Mentor, guide, and develop junior and mid-level… more
- BeOne Medicines (San Mateo, CA)
- …with senior stakeholders and cross-functional teams (clinical, medical, safety, CMC , commercial) across regions to achieve strategic business goals through ... knowledge sharing and collaboration. + Liaise and negotiate with cross-functional teams to expedite submission timelines and support resolve key regulatory issues in all relevant markets. + Mentor and guide junior staff in project planning, regulatory… more
- Integra LifeSciences (Plainsboro, NJ)
- …Operations** is responsible for the medical dispersion production activities for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality ... of our medical devices. This includes assigning and monitoring daily 2nd shift activities of production staff and partnering with other support departments to efficiently and compliantly complete work and work processes as per outlined production schedules.… more
- Parexel (Des Moines, IA)
- …update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes). - Execute timely data entry and validation in Veeva Vault RIMS ... for submissions and approvals. Regulatory Submissions - Review, prepare, and submit dossiers; negotiate with HAs to secure approvals. - Provide local input for change control and post-approval requirements. - Collaborate with global functions to obtain… more
- Lundbeck (Bothell, WA)
- …Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has ... supported commercial launch of Lundbeck's first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new… more
- ERP International (Anchorage, AK)
- …(RN-NCM) o National Academy of Certified Care Managers: Care Manager Certified ( CMC ) Licensure:** Current, unrestricted license in any one of the fifty States, ... the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the US Virgin Islands. Life Support Certification:** Possess and maintain a current AHA or ARC BLS Healthcare Provider certification. Security:** Must possess ability to pass a Government… more
- BeOne Medicines (San Mateo, CA)
- …service level to internal stakeholders (eg Clinical Operations, Regulatory, Quality, CMC ). + Work with Clinical Operations to understand clinical demand requirements ... and ensure alignment with study teams to supply plans and timelines. + Create supply and inventory plans and develop production schedules for clinical trial materials. + Monitor schedule adherence of production schedules and make course corrections if needed.… more
- Parexel (Sacramento, CA)
- …regulatory requirements. - Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: - University degree in Life Sciences, Chemistry, ... Engineering, or related pharmaceutical field; advanced degree (MSc, PhD, PharmD) preferred. - Minimum 5 years of biotech/pharma industry experience, including 2+ years in labeling/regulatory operations with global responsibility. - Experience leading teams in… more
- BeOne Medicines (San Mateo, CA)
- …service level to internal stakeholders (eg Clinical Operations, Regulatory, Quality, CMC ). + Work with Clinical Operations to understand clinical demand requirements ... and ensure alignment with study teams to supply plans and timelines. - Create supply and inventory plans and develop production schedules for clinical trial materials. + Monitor schedule adherence of production schedules and make course corrections if needed.… more
- Arup (San Francisco, CA)
- …AutoCAD and Revit MEP proficiency. - Familiarity with codes and standards, specifically CMC , IECC/ASHRAE 90.1, LEED energy efficiency and indoor quality and NFPA. - ... Strong interpersonal and communication skills essential for team-based work. - Presentation skills with colleagues and clients of all levels and commercial/financial awareness. - The ability to prioritize effectively, balance assigned work and exceptional… more
- Lundbeck (Deerfield, IL)
- …effective regulatory affairs cross-functional team on key labelling requirements ( CMC , Regulatory Operations, US Labeling and Advertising and Promotion, ... International regulatory). **REQUIRED EDUCATION, EXPERIENCE AND SKILLS:** + Accredited Bachelor's Degree. + 10+ years of experience within a pharmaceutical, medical device and/or biotech industry, with 7+ years of experience in Regulatory Affairs. + 3+ years… more
- Parexel (Harrisburg, PA)
- …in Microsoft Office Suite. **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified ... and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their… more
- ERP International (Hurlburt Field, FL)
- …Manager (RN-NCM) National Academy of Certified Care Managers: Care Manager Certified ( CMC ) **Experience:** One year of experience as an RN Case Manager ... post-graduation. License:** Current, full, active and unrestricted license to practice as a Registered Nurse from any state. Life Support Certification:** Possess a current AHA or ARC BLS Healthcare Provider certification. Security:** Must possess ability to… more
- ERP International (Twentynine Palms, CA)
- …Manager (RN-NCM) o National Academy of Certified Care Managers: Care Manager Certified ( CMC ) Life Support Certifications:** AHA or ARC BLS Security:** Must be able ... to pass a Government background check and obtain a Government security clearance. Pay Scale: _$60/hr to $75/hr,_ _to be determined based on employment options, qualifications, experience, and location_ **Job Locations** _US-CA-Twentynine Palms_ **Posted Date**… more
- Parexel (Charleston, WV)
- …BSL2 (Biosafety Level 2) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified ... and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their… more
- Parexel (Hartford, CT)
- …standard operating procedures (SOPs) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with ... qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet… more
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