- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT)… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, ... solutions to the world.Looking for someone with a growth mindset. The Director, Regulatory Affairs Liaison is responsible for:Developing regulatory strategy… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …biotechnology industry experience (including roles in research and development (R&D), clinical trials, regulatory affairs , or medical affairs Leadership ... of a drug development function such as Clinical Drug Development (preferred) or Medical Affairs . Experience managing teams and large-scale projects is essential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other...disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Internal relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs , Regulatory Affairs and other NNI ... , project teams, and investigators. Support recruitment & retention activities Obtain expert medical community input Regulatory liaison: Write and/or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager. Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …priorities and business needs. Relationships This position may report into the Field Director, Medical Affairs (or in smaller TA's directly into the TA head). ... About the Department The Clinical, Medical and Regulatory (CMR) department at...for scientific resources, communications, and training initiatives for the medical affairs team Serve on Clinical Trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …be a key and visible expert leader, he/she will engage the clinical, Medical Affairs and commercial organization and drive the product evidence strategies to ... Market Access and Pricing and other internal stakeholders such as Medical Affairs , Clinical Development, Marketing, Biostats, etc. Qualifications: Successful… more
- Merck & Co. (Rahway, NJ)
- …to our customers.Work effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , manufacturing, ... by actively synthesizing inputs from cross-functional teams including CORE, MA&P, Medical , and key marketsRepresent our Company's commercial point of view on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …external stakeholders. Collaborates with cross-functional teams, including sales, marketing, medical affairs , market access and policy/advocacy (MAPA), Centers ... of Excellence (COEs), regulatory affairs , other relevant NNI departments, and...and/or life cycle activities Health Systems Strategy: Collaborates with medical affairs and market access teams to… more
- Tris Pharma (Monmouth Junction, NJ)
- …of clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs , Product Development, Research and Development (R&D), Quality ... Assurance (QA), Pharmacovigilance, Medical Affairs , etc.) on strategic and tactical...team of direct reports Serves as a Subject Matter Expert (SME) and provides medical /scientific expertise by… more
- Merck & Co. (Rahway, NJ)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible… more
- Merck & Co. (North Wales, PA)
- …stakeholders across the enterprise including Global Marketing, Data & Analytics, Medical Affairs , Policy, Payer Marketing, Finance, Manufacturing, Sales, Global ... market development and promotional campaigns Serve as subject matter expert for market understanding and customer insights Collaborate with...Communications, Regulatory , Legal/Compliance Manage brand budget and act as profit… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose. The Role As part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director, USMA Solid Tumor ... This role will report to the VP/Head of US Medical Affairs and will be responsible for...& supports cross function launch activities Serve as a medical and content expert for internal and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with key stakeholders across the organization, including marketing, sales, compliance, IT, medical affairs , and senior leadership to ensure alignment and support ... and/or field systems preferred Proven knowledge of the pharmaceutical industry, including medical , regulatory , clinical processes and market dynamics HCP and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report and continued process verification ... root cause analysis, impact assessment, and CAPA/EC determination.Serves as Subject Matter Expert (SME) in preparation for and during internal and external … more
- Atlas Data Systems (Wilmington, DE)
- …strategies and optimize business processes using data insights. Collaborate with marketing, sales, regulatory affairs , medical affairs , and other ... effectiveness in project operations. Ensure all project activities comply with regulatory requirements and drive timely regulatory approvals through effective… more
- Genmab (Princeton, NJ)
- …KOLs, advisory boards, patient advocacy groups), internal stakeholders (eg, Research, Safety, Regulatory , Medical Affairs , Commercial), and internal decision ... components of regulatory submissions, safety documents) produced by CDT Act as medical expert and leader in interactions with external stakeholders (eg, … more
- FirstEnergy Corp (Akron, OH)
- …the strategic direction and lead the organization to ensure activities support regulatory compliance. - Advise on issues and updates regarding rate design, tariffs, ... system operations, and legal & regulatory standards. - Provide guidance in handling difficult or...on executing company strategy. - In collaboration with External Affairs , maintain relationships with governmental agencies and represent the… more
