- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Merck & Co. (North Wales, PA)
- …specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing ... Life Science, Medical Writing, Motivation Management, Prioritization, Project Management, Regulatory Compliance, Regulatory Documents, Science {+ 4… more
- Aequor (Thousand Oaks, CA)
- …/hour Urgent role. Shortlisting will begin EOD Weds 7/23 Standard business hours Supply Chain Senior Manager - Global Supply Chain Leader What you will do Let's ... reliable patient supply. With the end-to-end supply chain oversight of products, the Senior Manager will be responsible for establishing supply chain resolutions… more
- Merck & Co. (Rahway, NJ)
- …(e . g . , ICF documents/ amendments); Partners with the Study Manager on study deliverables. Ensuring CRF design supports data collection in alignment with ... mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) Ability to manage… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …(GMPs) and other applicable worldwide regulations and our Company procedures.- The Senior Specialist will become knowledgeable in regulatory requirements, cGMPs ... Job Description Job Description The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of ... methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role… more
- Genmab (NJ)
- …quality, and scientific integrity? At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our ... science through compelling clinical and regulatory documents. You'll be at the heart of a...experience authoring protocols, investigator's brochures, and clinical study reports. Senior level candidates should also have knowledge of Health… more
- Merck & Co. (North Wales, PA)
- …study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Merck & Co. (North Wales, PA)
- …execution elements (eg operational reviews, issue escalation/mitigations, presentations at Sr Management meetings, program level cross functional meetings and ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision ... technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM,… more
- Genmab (NJ)
- …the above by developing and writing corresponding SAS or other programs. The Senior Programming Manager may also serve as a compound lead.Responsibilities/tasks ... for Programming Manager , at least 6-8 years of experience for Senior Programming ManagerHas experience working in a global contextProficient in both written and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with customers. Relationships This position reports into a Vice President or Sr . Director within the National Account Market Access Teams. Internally, this position ... NNI, a self-starter who is self-led and keeps their manager up to date on progress and ensures no...and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Identifies and builds… more
- Merck & Co. (North Wales, PA)
- …Global Regulatory Affairs.--The AVP provides leadership and direction through senior -level and first-line managers and statistical staff focused on end to end ... teams both as a direct manager and a second line manager (ie, managers of managers)Demonstrated collaboration with senior cross-functional leadership in… more
- Repligen (Waltham, MA)
- …role is based in Waltham, MA, and will report to the Senior Manager of Supplier Quality.Responsibilities Supplier Performance Monitoring and ReportingCollect, ... Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate risks… more
- Novo Nordisk Inc. (Durham, NC)
- …Nordisk and help us make what matters. The Position Seeking an experienced to Sr level Process Engineer to support the bulk process tableting line. This role will ... equipment for the core processes to meet all customer, business & regulatory requirements through the following activities: People Focus, Process Focus, Equipment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …daily production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and ... controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Merck & Co. (Durham, NC)
- …our Manufacturing Division (Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our ... (written and verbal).-Ability to effectively influence key stakeholder groups (including senior and executive levels of an organization).-- Integrity - Stewardship… more
- J&J Family of Companies (Santa Clara, CA)
- …sonic pressure waves for the treatment of calcified plaque. **JOB SUMMARY** The Regulatory Compliance Senior Manager provides key strategic insight, ... States of America **Job Description:** Johnson & Johnson is hiring for a ** Sr . Manager , Regulatory Compliance - Shockwave Medical** to join our team located… more
