- 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
- Merck & Co. (Rahway, NJ)
- …Employee Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory ... experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience… more
- Vetrics Group (Washington, DC)
- …Process Analyst will be part of a team conducting international trade-related policy and regulatory analyses, developing strategic frameworks and plans, and ... Take and submit meeting minutes for all client meetings. Conduct policy and regulatory analyses and submit written summaries, reports, and findings to the… 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)
- …Customer Call Center, Enterprise Insights, Supply Chain, Procurement, Public Affairs, Public Policy , Regulatory , Legal, IT, Trade, Patient Safety and Compliance. ... insurance. The Company also offers time off pursuant to its sick time policy , flex-able vacation policy , and parental leave policy . We commit to an inclusive… 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
- 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
- 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
- TECO (Tallahassee, FL)
- …Provide assistance to State Government Affairs by reviewing proposed legislation concerning regulatory policy and other matters and providing feedback regarding ... Title: Regulatory Affairs Manager Company: Peoples Gas System State...facilitate development of company positions on energy and other policy matters. Development and implementation of action plans to… 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
- Southern California Edison (SCE) (Azusa, CA)
- …in project management. Preferred Qualifications u00a0 Understanding of California energy policy , CPUC regulatory processes, and clean energy programs. Experience ... Energy Revolution u00a0 Become au00a0Project Manager - Clean Energy & Regulatory Implementationu00a0at Southern California Edison (SCE) and build a better tomorrow.… more
- Klamath Tribal Health and Family Services (Klamath Falls, OR)
- …of duties in the major areas of human resource management; including regulatory and policy compliance, technical advice, professional recruitment and selection, ... appraisals and ensure all recommended pay increase are in line with policy . KNOWLEDGE, SKILLS, ABILITIES Knowledge or ability to learn Klamath Tribal Health… 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
- 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
- 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
- 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)
- …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
