- Genmab (NJ)
- …portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within ... work instructions, templates, and associated documentsThis position may also support regulatory policy and/or intelligence deliverables:Monitor the regulatory… more
- Novo Nordisk Inc. (WA)
- …and gathering insights from other departments (Corporate Tax, MA, Comm'l BUs, Medical, Regulatory , Legal, etc) Assigned policy areas may include, but are not ... and its long-term ambitions. Develops Novo Nordisk Inc (NNI's) policy positions, in line with Enterprise Strategy for tax,...company priorities and analyze the business impact of select policy proposals in areas such as tax policy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …identifying areas of potential non-compliance or operational risks.Responsibilities:Maintain regulatory procedural documentation, in line with company-wide policy ... centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of...Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …understanding of pricing implications and downstream impact of the evolving public policy , government, regulatory landscape and other relevant trends Identifies ... of pricing implications and downstream impact of the evolving public policy , government, regulatory landscape and other relevant trends Continuously… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory ... under development and post approval research, including the development of regulatory strategies to ensure effective achievement of regulatory /business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Merck & Co. (Rahway, NJ)
- …formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products ... product technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Genmab (NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... analyses requiring advanced statistical methodologies/techniquesRepresent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or… more
- Genmab (NJ)
- …Manager to help us tell the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a team that plays a critical role ... of high-quality clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You will help...your personal data and privacy. Please see our privacy policy for handling your data in connection with your… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functional teams, including sales, marketing, medical affairs, market access and policy /advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, ... required Proven knowledge of the pharmaceutical industry, including medical, regulatory , clinical processes and market dynamics, especially within specified therapy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project portfolio and prioritize and drive projects from inception through regulatory approval to global implementation.Requirements BS required, Ph.D. preferred in ... network and drive change management process from inception through regulatory approval to global site implementation.Candidate must have extensive experience… more
- Genmab (NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... requiring advanced statistical methodologies/techniques Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and collaborating with key stakeholders and functionsActively participates in all regulatory and internal audits of the facilityPartner and manage relationships with ... of work and compliance with all company policies and regulatory guidelinesHelps improve metric performance to drive team results...three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various ... talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and other...three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days,… 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
- Eisai, Inc (Nutley, NJ)
- …will be working with external key opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase II and Phase III studies, and ... critical milestones across programs in compliance with Eisai's SOP's and regulatory guidelines.Direct program level oversight of Clinical development plans (CDP) and… more
- Eisai, Inc (Nutley, NJ)
- …price reporting, patient support, as well as other pharmaceutical regulatory counseling. Essential Functions: Provides proactive and day-to-day legal support, ... state pricing-related laws and regulations, PhRMA Code and FDA regulatory guidelines.Serves as the legal representative for market access...equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related to US Talent Acquisition. Ensures utilized solutions are compliant with regulatory requirement and advises on the same. Ensures Talent Acquisition functions ... Acquisition processes so they are aligned with legal and regulatory guidelines. Ensure that the integrity of US regulations...also offers time off pursuant to its sick time policy , flex-able vacation policy , and parental leave… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Market Access and Public Affairs (MAPA), Field Sales, Commercial Excellence, Regulatory Affairs, Integrated Customer Engagement, Global and other relevant NNI ... device and digital market and solutions, including technological trends, regulatory landscape, and competitive dynamics Strong knowledge of the pharmaceutical… more
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