- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with clinical development staff.Consults with KEE's for advice on complex patient safety issues. Communications lead with HCP's (PI's, sub- PI's, nurses) ... Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts with a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business ... end-to-end processes and ensuring consistency and standardization across regions and functional areas.The role of the GPL involves developing and maintaining… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Represents US medical affairs function as a member of the various cross- functional forums including, Publications Planning, Clinical and Safety sub-teams, US ... in Global Medical Affairs committees as requested. Serves as US Medical Affairs Lead , to gain strategic and planning alignment across the matrix team and the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAre you well-versed in EHS (Environmental, Health, and Safety ) practices and possess a strong enthusiasm for leading digital transformation ... to join our team as an Environmental Health & Safety (EHS) Digital Solution Senior Specialist. -- We are...leveraging technology to drive EHS excellence and who can lead the organization in embracing digital innovations within the… more
- Merck & Co. (Rahway, NJ)
- …to be able to share and communicate that knowledge through training of analystsThe functional lab area lead will be responsible for overseeing the day-to-day ... Job DescriptionPosition Description: Senior Scientist, Microbiology (Lab Lead ) - Analytical Research & Development (Onsite) Small Molecule Analytical Research and… more
- Flex-N-Gate Corporation (Allen Park, MI)
- …lighting components and other automotive components including eBrake / ePedal. Responsibilities Lead functional safety engineering activities for product ... opportunity for hard-working and skilled individuals. Scope of the Position The Functional Safety Engineer will ensure the successful implementation of standards… more
- Merck & Co. (Durham, NC)
- …commissioning and qualification, licensure, and ramp up to full production.Durham's Lead Technician, Operations will be a leader with strong interpersonal, ... in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include Healthcare professionals, HAs, ECs, DMCs, and Academia. Line management of Senior Global Safety Lead (s), Global Safety Lead (s) and Global ... deliverables of the safety surveillance team Chairmanship/membership of the NN cross- functional safety committees Participate as a member of the first … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Lead HEPA Certification Technician will provide direct leadership to the HEPA certification team, represents the team for site wide HEPA ... for HEPA certification sitewide needs Provides support to cross functional workstreams in development of appropriate measurement methods, including implementation… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Aseptic Manufacturing LeadPosition Summary:The Aseptic Manufacturing Lead plays a critical role in overseeing aseptic manufacturing activities. A strong background ... microbiology and experience in aseptic manufacturing are required. The Aseptic Manufacturing Lead will actively participate on the production floor by leading a team… more
- Merck & Co. (North Wales, PA)
- …the necessary processes to ensure high quality individual case and aggregate safety reporting. Interpret PV regulations related to drugs, vaccines, biologics, and ... with all of company's business units to ensure compliance and patient safety .Assist in the development and leadership of team members.Develop and implement… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the Quality team based in Raritan, NJ. Role OverviewThe QA Document Control Lead role is an exempt level position with responsibilities for supporting the document ... and complex projects, provide status reports, and coordinate with cross- functional departments.Support Document Management system users with workflow handling and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …PL, CCDS, CCPL)for new products or products in the development phase. Independently lead cross functional teams through all labeling discussions with the ... in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Expand and lead our Data Stewardship Working Group (DSWG) across functional areas. This includes: oFacilitating and coordinating data issues across business ... lineage, and adding context metadata in a structured fashion Lead and work with functional business data...Records, Electronic Signatures o 21 CFR § 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …interdependencies for assigned clinical study (-ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross- functional Clinical Study Oversight ... writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Lead the CRO and...the assigned clinical study and responsible for leading the cross- functional study team, project managing and coordinating with internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets ... interacts across the RA function globally and interacts across functional as well as regional areas. This position often...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' externally ... operational strategies for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and outcomes, addressing… 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 ... demonstrated decision-making capabilities. Provides medical and scientific expertise to cross- functional DSI colleagues.Responsibilities:Medical Monitoring:For studies in which Medical Monitoring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narratives- May lead the development and updates of the Investigator's ... demonstrated decision-making capabilities Provides medical and scientific expertise to cross- functional DSI colleaguesResponsibilitiesMedical Monitoring- For studies in which Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. He/she ... for each respective program. This Clinical Science (CS) Group Lead will be responsible for overseeing multiple program-level CS...clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA… more
