- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director , Omnichannel Marketing and Media position reports to the Senior ... Director , Omnichannel Marketing (HCP and Patient). The associate director will also partner closely with key internal partners to deliver omnichannel and… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... in due diligence activities and represents global function on study and project teamsProduces independent writing for publications & regulatory documentsServes… more
- Fidelity TalentSource LLC (Boston, MA)
- Job Description:The RoleThe Director of Product Disclosure Policy and Regulatory Strategy is responsible for establishing and administering guidelines for the ... Fund Investment Operations (FFIO) regulatory readiness focused on emerging regulatory matters impacting our business. The Director will:Be the primary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. This position may propose strategies for external data… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related ... development.#LI-TS1Eisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Outsourcing is from :157,200-206,300Under… more
- Aequor (Newbury Park, CA)
- …in SharePoint, has working experience with the Six Sigma method and project management experience. The type of qualities/characteristics the hiring manager is ... requires resourcefulness and critical thinking skills.) Job Title: Sr. Associate - Records Information Management & Systems (RIMS)Job DescriptionKey responsibilities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... changes for portfolio biologics and determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Associate Director , Digital Innovation and Omnichannel Engagement will be responsible for the ... best practices within Scientific Communications and Medical Affairs.Drive oversight, project management and delivery of digital initiatives.Partner with IT team… more
- Merck & Co. (Rahway, NJ)
- …FI/CO modules.- This role reports to the Global Financial Business Management Director . Responsibilities: Leadership and Management: Lead a global team of 6-8 ... FI-General Ledger, Controlling: CCA, PCA, IO, CO-PA).- Familiarity with SAP Project Systems (PS) helpful. Foster a culture of excellence, collaboration, and… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Project Manager within the Strategy Realization Office (SRO) function of GMSA at our company, the successful applicant will play a critical role ... and timelines are consistently met.Facilitate the creation and approval of all project deliverables, including maintaining detailed Project Plans, Risk Plans,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs, HEOR and other stakeholders to ensure… more
- Insmed Incorporated (Bridgewater, NJ)
- …in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of the ... ongoing growth of our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not have any direct… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position has experience working on Phase I-IV study ... and/or pharmaceutical industry across multiple therapeutic areas and experience with regulatory submissions and inspections. Finally, this position has strong skills… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The project teams will be defined based on the ... needs and the respective development stage of the project . The CMC Lead will support the Sr. CMC...1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences… more
- Merck & Co. (Rahway, NJ)
- …objectives utilizing external contractors including GMP qualification as well as site/ project selection.- Additionally, the incumbent would serve as the bridge ... complex Quality-related process reviews and/or investigations under minimal supervision.Provides project leadership in area of expertise in own discipline (such… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this job is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and programming submission. It will ... and build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities- Supporting project lead on outsourced projects, act as statistical programming subject matter… more
- Insmed Incorporated (Bridgewater, NJ)
- …Research groups. The role will provide scientific and strategic guidance to global project teams and will oversee the internal and CRO resources as they relate ... in preclinical study design and documentation as needed.Contribute to regulatory document writing (eg IB, IND, Integrated Summary of Immunogenicity).Engage… more
