- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead actively...benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Manufacturing Practices (cGMP), safety procedures, quality standards, Occupational Safety and Health Administration (OSHA) standards, other regulatory agency ... in clean utilities validation activities during project life cycle.You will lead or support overall compliance requirements for the Utilities areas, including… more
- Aequor (Waltham, MA)
- …of large capital projects/investments with lab operations. Solid understanding of Health , Safety , Environmental and Legal requirements for operations. Clear ... software, equipment, and chemical requirements is an advantage.Primary Responsibilities: Lead by example to promote an inclusive, motivating work environment… more
- Merck & Co. (PA)
- …scientific background and leadership skills to join our team as the Regional Cardiovascular Lead Manager for the East District. In this role, you will lead ... including overnight travel, and for meetings at HQ.The Regional Cardiovascular Lead Manager will report to the Director of Regional Cardiovascular Team.-Primary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the DSI Call Center. Provide oversight of ICSR processing activities including, Safety Information submission to Health Authorities and License Partners, ... and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical ... diseases and immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing… more
- Merck & Co. (South San Francisco, CA)
- …experience in complex cellular model/assay development, mechanistic pharmacology, and lead discovery support to join our Quantitative Biosciences (Pharmacology) ... and assay protocols, and comply with all laboratory training and safety requirementsCollaborate with colleagues on multi-disciplinary project teams to provide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global sustainability websites and value report, arranging and supporting Environmental Health and Safety (EHS) audit requests. Qualifications: Successful ... of the company's Compliance Department and will report to the US Sustainability leader and will 1) manage the US Environmental Social Governance (ESG) Sustainability… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Resources, Site Leadership Team members, and peers.Harmonize with Environmental, Health , and Safety personnel, Product Development, and Quality/Manufacturing ... requirement.Experience directly supervising employees is preferred.Ability to work with and lead others in a team environment.Demonstrated ability to develop and set… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narrativesMay lead the development and updates of the Investigator's Brochure ... assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Merck & Co. (Rahway, NJ)
- …medical breakthroughs. We are looking for a collaborative, self-motivated -scientific leader with expertise in downstream bioprocessing to join Biologics Process ... development.Responsibilities include, but are not limited to:Serve as a scientific leader to shape and drive innovation across the Biologics pipeline, strategy,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …most diverse and collaborative groups within the organization. From health -care-provider interactions and developing and implementing regulatory strategies with the ... the team has access to critical knowledge required for cross CMR engagement. The leader will be responsible for leading a team to deliver on the responsibility of… more
- Merck & Co. (Rahway, NJ)
- …of Biologics Analytical Research & Development (BAR&D) seeks a driven leader to advance and commercialize complex biotherapeutics.The Director of Compliance, ... compliance across multiple sites, managing regulatory audits, internal quality and safety audits, quality notices, CAPA management as the business area… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the ... for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, internal company procedures and… more
- Merck & Co. (Rahway, NJ)
- …next medical breakthrough.Our team in Rahway, New Jersey, is seeking an exceptional leader who is passionate about leading a team of Scientists to deliver analytical ... enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable… more
- Merck & Co. (North Wales, PA)
- …for Product Manager - PV Case Intake and Processing. Reporting into Product Line Lead Patient Safety and Quality & Compliance, this position will be responsible ... PV information to internal and external stakeholders, such as regulatory authorities, health care professionals, and patients.- Lead PV projects: Partnering with… more
- Merck & Co. (Rahway, NJ)
- …development activities, compliance investigations/change management, authoring of GMP documentation, and lead other staff in the pilot plant as needed. The position ... is responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well...plant. The Process Engineer position reports to a Facility Leader and the successful candidate will be an integral… more
- Merck & Co. (Rahway, NJ)
- …BLAs for the company's pipeline.Manage large multifaceted projects as the leader of a cross-functional team.-Ensures project results meet requirements regarding ... and status updates to project sponsors and management.Champion compliance and safety ; promote a culture of diversity, inclusion, and equity. Minimum Education… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Device Product Stewardship will lead a department of up to 15-20 personnel overseeing technical support and product stewardship ... management, performance monitoring, continuous improvement activities that ensure the safety , effectiveness, and compliance of the company's products.- The… more
- Merck & Co. (Rahway, NJ)
- …of GMP documentation. The position is responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well as ensuring facility ... success of the pilot plant. The Process Engineer position reports to a Facility Leader and the successful candidate will be an integral member of the SSO process… more
