- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Development Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to ... a difference? The Position This leadership role is accountable for developing the safety strategy, major safety deliverables for assigned programs within the US… more
- Merck & Co. (Rahway, NJ)
- …your expertise.We are looking for a skilled and experienced individual to join our team as an Environmental Health & Safety (EHS) Digital Solution Senior ... Job DescriptionAre you well-versed in EHS (Environmental, Health, and Safety ) practices and possess a strong enthusiasm for leading digital transformation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the Product Labelling Committee (PLC) Review Group Review/approve deliverables of the safety surveillance team Safety surveillance of Novo Nordisk ... External stakeholders include Healthcare professionals, HAs, ECs, DMCs, and Academia. Line management of Senior Global Safety Lead(s), Global Safety … more
- Merck & Co. (Rahway, NJ)
- …investigations and change management .Familiarity with US and EU GMP and Safety compliance regulationsExperience in Process Hazard Analysis (PHA) and/or Level ... that provides a high degree of technical and project management responsibility. The Associate Director - Process /Facility...selected candidate is expected to lead and mentor a team of process /facility engineers and foster a… more
- Merck & Co. (Rahway, NJ)
- …Operations & Clinical Supply.- Primary Responsibilities: Manage, develop, and grow a team of process engineers, tasked with becoming equipment and facility ... clinical supply manufacture of our Company's drug product pipeline.- The FLEx Process Engineering Lead drives process development expertise, equipment and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is responsible for working with the business lead to ensure effective team operations through meeting management , development plan/timeline management , ... professional pharmaceutical/academia/healthcar industry experience required- Proven expertise in project management required- Strong knowledge of patient safety … more
- Merck & Co. (North Wales, PA)
- …regulation with all of company's business units to ensure compliance and patient safety .Assist in the development and leadership of team members.Develop and ... the necessary processes to ensure high quality individual case and aggregate safety reporting. Interpret PV regulations related to drugs, vaccines, biologics, and… more
- Novo Nordisk Inc. (Durham, NC)
- …grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position Support people, equipment ... for our operations areas to meet business and regulatory requirements. Provide process solutions for routine to moderate complexity issues. Support training for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …insights to the lines of business Develops supplier selection criteria and facilitate team members through a disciplined strategic sourcing process focused on ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Novo Nordisk Inc. (WA)
- …safety , rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance) for monitoring and site management activities. Takes ... (subset of) NACD and/or as part of a global team and as aligned to a business case, goals...for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities relevant to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and insights to the lines of businessDevelops supplier selection criteria and facilitate team members through a disciplined strategic sourcing process focused on ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …align with architectural standards. Relationships Reports to a member of the IT Management Team . Interacts with internal stakeholders across business units as ... processes or areas Works on the projects and initiatives assigned by IT management team Leads in the development and/or maintenance of technical documents.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on process implementations and metrics. - Cross-functional and Global Team Participation : Proactively collaborate with other GxP quality representatives and act ... process support; ensure timely and effective preparation and management of HA inspections, including facilitation of respective regulatory inspection preparation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …outputs, reviews clinical study protocols and the Clinical Study Oversight Plan,day-to-day management of DS Safety Notification Letter (SNL) System and manages ... oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act as PV… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program ... assessment of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety ... assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of… more
- Merck & Co. (Durham, NC)
- …Matter expert for LOTO and permit writing for maintenance activities, Safety Management Information Systems (SMIS) transactionsKnowledge of mechanical/electrical ... People Management / Leadership: Provide leadership to the Maintenance team including coaching, development, and performance management .Ensure a culture of… more
- Merck & Co. (Durham, NC)
- … process . Individual will possess the ability to lead a small team , train others and contribute to process improvements.Responsibilities may include but ... and prepares equipment used in production.Identifies and addresses compliance, environmental, safety , and process deviations as appropriate while notifying… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the CRO and vendor selection process in collaboration with the study team and outsourcing procurement management .Lead the creation of the CRO scope of ... site identification activities in collaboration with the CRO and the study team . Oversee the site qualification process .Monitor clinical trial performance and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …best practices. Assist or lead the development of Standard Operating Procedures (SOPs) and process improvements. Conduct team meetings with direct reports or a ... the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and… more
