- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This ... and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU SmPC, PIL,… more
- Merck & Co. (North Wales, PA)
- …Global Marketing, Data & Analytics, Policy, Payer Marketing, Global Communications, Regulatory , Legal/ Compliance Partner with other Product Marketing ... to join our US marketing team as the Associate Director , Product Marketing Owner - HCC /...presence Preferred Skills : Understanding of US commercial and regulatory requirementsFamiliarity with agile tools like Jira and MuralNOTICE… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) ... tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents ... ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Must be well-versed in pharmaceutical brand marketing, pharmaceutical industry, legal, compliance and regulatory , convention industry to provide recommendations, ... areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be responsible for… more
- Merck & Co. (Rahway, NJ)
- …software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product development to ... compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics expertise supporting delivery of small molecule, peptides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth ... knowledge of regulatory authority's requirements.Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide… more
- Merck & Co. (Rahway, NJ)
- …participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director , US Market Access Contracting sits within the National Contract Operations and Supply Chain Team (NCOSC), which delivers best-in-class, ... and Infusion companies for our Company's commercial and government business.-The Director , US Market Access Contracting reports to the Executive Director… more
- Merck & Co. (Rahway, NJ)
- …formulation development and GMP clinical supply manufacture of our company's drug product pipeline.- The FLEx Non-Sterile Production Lead will steer this facility ... trials.- Close partnership with supply chain colleagues from Quality, Regulatory Affairs, Facilities Management, Engineering, and Analytical will be required… more
- Tris Pharma (Monmouth Junction, NJ)
- …materials, activities and related communications and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, ... from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior Director , Head… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …hires during on-boarding and provide on-going support, as determined by Field Director Ensure personal compliance with all internal/external SOPs/rules and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Merck & Co. (Rahway, NJ)
- …and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and ... Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our… more
- Merck & Co. (Rahway, NJ)
- …Experience and Skills: Knowledge of Investigational drug regulatory requirementsAudit experience: safety, environmental, compliance /qualityUnderstanding ... (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focus even under adversity Operational mindset and continuous improvement: Considers compliance , regulatory , quality assurance and other requirements when ... Curation, Activation and Promotion - Collaborate with business partners (Marketing, Product Marketing, Field Marketing, Sales, Creative Agencies (as Needed) And… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director , Global Process Validation as part of the Technical Operations team based ... it is to deliver a best-in-class high volume marketed CAR-T product . The validation scope comprises a multi-site global manufacturing network responsible… more
- Insmed Incorporated (San Diego, CA)
- …represent Insmed Gene Therapy as subject matter expert during external and internal regulatory submissions and compliance inspections. Travel will be required to ... and Best Medium Workplaces™ lists.OverviewJoin the Technical Operations team as Associate Director of MSAT where you will support pipeline programs that change… more
- Eisai, Inc (Raleigh, NC)
- …microbiological assays.Thorough technical understanding of analytical laboratory compliance requirements and regulatory expectations.Demonstrated understanding ... your profile, we want to hear from you. Essential Functions Overall leadership of the Product Quality QC Biologics team. US staff are both remote and based out of… more
