- Novo Nordisk Inc. (Plainsboro, NJ)
- …provide regulatory guidance on commercial labeling materials to ensure compliance with CFR and FDA labeling requirements Identify labeling issues, troubleshoot, ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...(RA), Supply Chain, and HQ colleagues to ensure labeling compliance and accomplish company goals. Key Responsibilities Review and… more
- Genmab (Plainsboro, NJ)
- …Genmab products Build strong relationships with key external stakeholders including regulatory agencies, professional societies, and key opinion leaders ... for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be primarily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …dynamics, especially within specified therapy area preferred Strong understanding of regulatory , compliance , and ethical considerations in engaging with ... affairs, market access and policy/advocacy (MAPA), Centres of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with ... affairs, market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Senior Strategist will play a vital role in developing healthcare professional (HCP) market development strategy and content development with a focus on ... with sales, marketing, medical affairs, market access and policy/advocacy (MAPA), regulatory affairs, and other relevant departments to ensure that educational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …material. Ensure quality control of marketing content in alignment with compliance standards Continued Improvement: Ensure pull-through of 'test and learn' ... required Proven knowledge of the pharmaceutical industry, including medical, regulatory , clinical processes and market dynamics, especially within specified therapy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic… more
- Merck & Co. (Rahway, NJ)
- …site, region, and global business partners to drive prioritization of regulatory compliance , continuous performance improvement, and integration of EHS ... Accountable for all environmental, health, and safety (EHS) program execution and compliance at a portion of our Manufacturing Division's Animal Health Sites.Leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads (RQLs), ... the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from...the quality landscape across regions. This may include assessing regulatory intelligence and industry best practices and sharing with… more
- Merck & Co. (Rahway, NJ)
- …bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The successful candidate must function well ... Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related fields is preferred A minimum of eight (8) years combined pharmaceutical, legal, regulatory , and compliance experience required OR a minimum of six (6) ... the Department At Novo Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Programs, Patient Safety, Quality, NNI IT and Telephony, Medical Information, Compliance , Regulatory , Legal and Privacy. External relationships include Patient ... Support program vendors and professional services (including technology and platform support). Essential Functions Partners with PSS Program Management team to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …marketing, market access, commercial insights and analytics, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... contractual arrangements, SOPs, KPIs, and budget. Ensure adherence to all compliance and regulatory requirements Fiscal management: Demonstrate fiscal discipline… more
- Merck & Co. (Rahway, NJ)
- …development and maintenance of Core and US Labeling for assigned products, ensuring compliance with internal and regulatory standards.You will assist in the ... significantly to our company's product labeling.This role provides opportunities for professional growth, strategic planning, and allows you to demonstrate your… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... coaching/guidance to individual contributorsMaintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring … 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,...architecture. Advocates for good architecture and design practices and compliance in all relevant areas. Assists IT and business… more
- Merck & Co. (Rahway, NJ)
- …tumor size and survival. A Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring ... regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),...Proficiency in R, NONMEM,MATLAB, Monolix or other modeling software. Professional working proficiency in written and verbal communication. Current… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Novo Nordisk Inc. (Minneapolis, MN)
- …SOPs and working practices Complies with all guidelines, policies, legal, regulatory , and compliance requirements Ensures effective administrative management of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...as well as Managed Care and Government by using academic/ professional credentials and scientific expertise to communicate with health… more
- Merck & Co. (Rahway, NJ)
- …other R&D departments that have logistics support needs and/or Trade compliance consultation or operations support needsEnsure an exquisite partnership with Global ... Clinical Trial Operations, Regulatory and other Development Sciences and Clinical Supply (DSCS)...with external partners like freight forwarders, couriers and brokers.Ensure compliance with all applicable regulations impacting clinical trials and… more
Related Job Searches:
Bank Regulatory Compliance Professional,
Compliance,
Compliance Professional,
Professional,
Regulatory,
Regulatory Compliance