- Merck & Co. (North Wales, PA)
- …concepts that meet business objectives and minimize regulatory risk-Provide regulatory consultation in the development and implementation of US marketing ... Job DescriptionReports to the Director /Senior Director in the Office of...review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launchUnderstanding of… more
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC… 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) ... Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This… more
- Tris Pharma (Monmouth Junction, NJ)
- …communications and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, oversees implementation , and monitors ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …capture to support CDx regulatory submission or associated drug regulatory submissionsResponsible for implementation of clinical trial assays at Diagnostics ... research areas centered around rare diseases and immune disorders.Job Summary: The Director , Diagnostic Sciences will be responsible for end-to-end process for CDx … 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)
- …authority. Experience providing commercial input on such activities as: Target product profile development, global regulatory filing strategy, launch readiness ... Job DescriptionWe are currently recruiting for an Associate Director Global Oncology Marketing Hematology for a non-covalent inhibitor in Leukemia and Lymphoma.- A… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Job Summary Deliver the development and implementation of informatics systems and programs to support the business functions ... include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be responsible for ... Marketing leadership to oversee and execute all aspects of field-based programs, product theaters, & national broadcasts in conjunction with the Brand teams. This… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Director , HCP Marketing is responsible for developing and implementing strategic marketing programs for ... and customer experiences aligned to relevant business objectives for the product . Specific job responsibilities include: designing, implementing and evaluating the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal stakeholders ... include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Support through open and effective communication and business partnering the cross-functional implementation of the Vision and Mission of Global QA. Drive a Culture ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary Deliver the development and implementation of Research & Development (R&D) informatics systems and programs to ... include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Team leads the US marketing efforts for Novo Nordisk's robust cardiometabolic product portfolio, which includes world class therapies for the treatment of diabetes, ... Executive Management and Board of Directors. Relationships Reports to the Sr Director Omnichannel Engagement. Responsible for the management of a media team that… 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
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Associate Director , HCP Marketing is responsible for developing and implementing strategic marketing programs for ... and customer experiences aligned to relevant business objectives for the product . Specific job responsibilities include: designing, implementing and evaluating the… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. SummaryThis position serves in a pivotal role, leading the creation and implementation of sourcing strategies for a specific set of R&D categories (CRO, ... complex initiatives of high dollar value from inception through to implementation . Demonstrates ability to handle global projects through established interactions… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customers. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing ... and pricing and contracting strategy for a key Novo Nordisk product category. Ensures alignment between the value communication and contracting strategy… more
