- Insmed Incorporated (San Diego, CA)
- …of continuous learning, cross-training, and operational excellence.In partnership with Regulatory Operations , and/or third-party service providers, ensure high ... Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director, Regulatory Affairs will serve as the regulatory leader on… more
- The Pivot Group (Coopersville, MI)
- …advancement. Required Skills: *Process Improvement *Six Sigma *Offers *Search *Business Operations * Regulatory Compliance *Daily Operations * Operations ... Description: Are you a dynamic leader with a passion for optimizing business operations and driving organizational success? The Pivot Group Network is dedicated to… more
- Merck & Co. (Rahway, NJ)
- …late clinical development through commercialization, with practical insight into how these operations generate CMC regulatory content - Understanding of CMC ... operations , technology transfer, control strategy development, and regulatory authoring requirements that inform automated filing generation - Hands-on experience… more
- Merck & Co. (Rahway, NJ)
- …for CMC. Strong understanding of integration and partnering with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areas. ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings. Collaborate with key stakeholders across the organizations… more
- DERMCARE MANAGEMENT LLC (Hollywood, FL)
- …multiple sites to ensure efficient planning, execution, and completion. Ensure all operations comply with regulatory standards, Good Clinical Practices (GCP), ... Road Warrior Job Category Research Description The Regional Director of Clinical Operations plays a key leadership role in overseeing the daily operations… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working closely with our QA organization to implement ongoing learnings from regulatory inspections.Engage and motivate Clinical Operations employees to execute ... around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ensure the effective… more
- Merck & Co. (Durham, NC)
- …network: build and maintain strong and trusting relationships with site technical operations , quality, regulatory , stability, and other stakeholders to ensure ... will partner with the team Technical Product Leader as well as site Technical Operations and other key members of the Technical Product Council to implement the… more
- Merck & Co. (Durham, NC)
- …network: build and maintain strong and trusting relationships with site technical operations , quality, regulatory , stability, and other stakeholders to ensure ... will partner with the team Technical Product Leader as well as site Technical Operations and other key members of the Technical Product Council to implement the… more
- Kenai Therapeutics (San Diego, CA)
- …of clinical trials, with a focus on meeting project milestones, timelines, and regulatory requirements. The VP of Clinical Operations will collaborate closely ... Reporting to the Chief Medical Officer (CMO), the Vice President of Clinical Operations is a senior leadership position responsible for overseeing and advancing all… more
- Eisai, Inc (Nutley, NJ)
- …years significant clinical pharmaceutical experience (ie, clinical development or operations , regulatory compliance).Substantial experience in Clinical Quality ... area.Anticipate immediate and long-term risks to quality support for overall operations continuity and propose/ implement pre-emptive actions through engagement with… more
- Elucent Medical, Inc. (Eden Prairie, MN)
- …with cross-functional teams including Systems Engineering, Software, Quality, Clinical, Regulatory , and Operations to define system-level requirements and ... devices and have a deep understanding of product lifecycle, regulatory requirements, and cross-functional development environments. Supervisory Responsibilities: Recruits,… more
- Merck & Co. (Rahway, NJ)
- …acumen such as product knowledge, healthcare systems, payors and customers, regulatory , business operations and reputational risks while working intimately ... with our global business partners.-In addition, individuals will use data analytics to gain insights into business practices and the execution of the company's strategy. Individuals will be based in the global headquarters in Rahway, NJ.Opportunity to Innovate… more
- Synterex (Boston, MA)
- …will partner cross-functionally with client teams in Clinical Development, Clinical Operations , Biostatistics, Regulatory , and Program Management in leading the ... specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus… more
- Merck & Co. (Rahway, NJ)
- …the efficient management of data across the organization, including compliance with regulatory standards, and the optimization of laboratory operations and ... and inventory strategies into actionable plans and benefits DD&T lab operations .Collaborate across DD&T sub-functions, regulatory affairs, quality assurance,… more
- Rocket Lab Corporation (Long Beach, CA)
- …assemble satellite hardware and software that supports other satellite missions. SENIOR RF REGULATORY LEAD ENGINEER I/II Join our team as the Senior RF Regulatory ... the acquisition of RF licenses for Rocket Lab's cutting-edge systems and operations , ensuring full compliance with both local and international regulations. You'll… more
- Nura Bio (South San Francisco, CA)
- …diseases of the central, peripheral, and ocular nervous system. The VP/Head of Regulatory Affairs will be a key member of our clinical leadership team, responsible ... for developing and executing regulatory strategies to support the company's product development and...changes and trends and communicate their impact on company operations . *Collaborate with external partners, consultants, and contractors to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cultures. Additionally, he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will have ... therapeutic areas and is capable of leading DM activities to support regulatory submissions and inspections. Finally, this position has advanced skills in continuous… more
- Merck & Co. (Rahway, NJ)
- …readiness as well as preparing for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is ... Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the...Preparation and Management:The CQOM is responsible for maintaining current regulatory inspection knowledge as it relates to Good Clinical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project management in cross-functional drug development teams or clinical, regulatory , pharmaceutical sciences/technical operations in the biopharmaceutical ... Biotech is seeking Senior Project Manager, PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible for… more
- Cypress Healthcare Partners (Salinas, CA)
- …Degree At least one year of Leadership Experience Experience with laboratory operations , regulatory compliance, and quality assurance PREFERRED Bilingual in ... SUMMARY The Phlebotomist Manager oversees Phlebotomists to ensure efficient lab operations , maintaining compliance with COLA, state, and federal regulations. This… more
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