- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary: The Associate Director, Regional Marketing Conventions & Field Programs will be ... and more, while ensuring adherence to DS policies and procedures. The Associate Director, Regional Marketing Conventions & Field Programs is responsible for managing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …develops strategy, prepares content templates and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, ... (eg, preIND, EOP2, pre-NDA, Type C, Scientific Advice) with supervision, from preparation of the briefing book, to training and preparing the technical team,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC ... Conference on Harmonization (ICH), and other applicable regulations. This includes preparation , review, and approval of CMC documentation for BLA Supplements (PAS,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with us? The Position The purpose of the Peer to Peer Tech & Innovation Associate is to assist in the management and optimization of the Peer-to-Peer HCP engagement ... the accuracy and timeliness of HCP engagement records. The associate will support efforts to adapt and optimize systems,...and audit all final bills, and assist in the preparation of reports HCP Compliance Management: Support the management… more
- Merck & Co. (Rahway, NJ)
- …both analytical experimental design and biotherapeutic pipeline programs. Finally, this Associate Principal Scientist will be a partner in problem solving, building ... ADCs.Experience in conducting biologic mass spectrometry experiments, including sample preparation and optimization, liquid chromatography separation, mass spectrometer operation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Associate as part of the Technical Operations team based in Raritan, NJ.Role ... to develop professionally.Support investigation efforts as required.Responsible for audit preparation and participation.RequirementsHS Diploma required with 3 - 5… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Strategic Planning provides strategic insights and direction ... (QBRs) overview for Investor Relations and OBU to support Earnings Call preparation by liaising with Regional Marketing/Insights teams to compile Brand Performance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director of ERP Applications is responsible for overseeing and enhancing ... refine and prioritize business requirements. Assist in the technical preparation of Business Process Procedures, functional specifications, test scenarios, end-user… more
- Merck & Co. (Lower Gwynedd, PA)
- …developing and expanding your career.We are seeking a highly motivated Associate Principal Scientist to join the Department of Pharmacokinetics, Dynamics, ... Hands-on familiarity with liquid handlers and other automation platforms for sample preparation and assay process is strongly desired. Candidates must be able to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development and implementation.Supports packaging design and patient kit supply preparation , label generations and approvals and associated interactions with ... interactions with Vendors on packaging design and patient kit supply preparation , label generations and approvals. Support regular vendor/sponsor discussions to… more
- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director, Quality Assurance - Analytical,GMP has responsibility for the ... equipment are carried outResponsible for assisting in any Health Authority inspection preparation , acting as SME when needed and in providing or reviewing responses… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director, HCP Marketing is responsible for developing and implementing strategic marketing programs ... promotion plans, medical education plans, sales forecasts, budgets. Direct preparation , planning and implementation of conventions. Develop and enhance patient… more
- Merck & Co. (Rahway, NJ)
- …with an emphasis on process equipment and critical utilities. Support the preparation and approval of qualification protocols and summary reports. Support new ... equipment receipt, testing, and commissioning. Maintain GMP documentation where applicable, such as GMP engineering drawings, equipment database tracking, and Key Performance Indicator (KPI) data. Lead, facilitate and/or participate in investigations, and any… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other functions in Technology Unit, and key business partners.- Requires preparation and presentation of comprehensive internal and external presentations, and ... decision memo, encompassing all relevant areas of the relevant tasks Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by managing labeling development or approval for either the US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, ... prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU SmPC, PIL, CCDS). Independently leads cross functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across ... all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for the company's growth, thereby… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including leading team through creation of briefing materials and meeting preparation Lead and/or support global filing activities for submissions Present regulatory ... strategies including communication of regulatory risks and associated mitigation plans to management and other internal stakeholders Perform regulatory review of all clinical and nonclinical documents for submissions, eg, clinical protocols and study reports,… more
- Novo Nordisk Inc. (WA)
- …sites to meet country enrollment and retention targets Participates in the preparation , conduct and follow-up of audit and inspection activities, collaborating with ... relevant internal and external stakeholders to develop and implement Corrective and Preventive Action Plans (CAPA) Shares information, collaborates and provides relevant input and guidance to other areas within NACD, CMR, and Global partners Demonstrates… more
- Aequor (Thousand Oaks, CA)
- …GxP Quality Management Review. Coordinating and Facilitating material creation and preparation sessions. Working with cross functional metric owners to ensure ... Lead coordination activities in support of GxP Management Review preparation including: Coordinate material generation, scheduling of review sessions, support… more
- CHRISTUS Health (Alamogordo, NM)
- …to department Policies & Procedures. Performs required equipment maintenance, preparation , cleaning, and sterilization per department Policies & Procedures. ... to department Policies & Procedures Performs required equipment maintenance, preparation , cleaning, and sterilization per department Policies & Procedures.… more
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