- Daiichi Sankyo, Inc. (Bernards, NJ)
- …provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc ... processes for record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory labeling-related activities. Updates internal processes to ensure compliance with health authority requirements and expectation Physical Requirements ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Merck & Co. (North Wales, PA)
- …and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high-quality standards.- Product managers must ... Product Line Lead Patient Safety and Quality & Compliance , this position will be responsible for managing the...Laboratory and Clinical practices, Computer Systems Validation, and other global regulatory requirements that impact IT systems… more
- Merck & Co. (Rahway, NJ)
- …and execute media relations strategies and outreach campaigns for strategic product prioritiesDemonstrate deep understanding of media and regulatory landscape ... Job Description Overview: The Director, Global Media Relations, is responsible for developing and executing a global media strategy that showcases our Company's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and… more
- Merck & Co. (North Wales, PA)
- …industry experts, patients, and regulators, and in engaging with global regulatory authoritiesProgram Leadership:-Demonstrated success in managing large-scale, ... of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results, document… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Global Pharmaceutical Communications The role of Director, Global Pharmaceutical Communications - New Products is a unique opportunity ... the world's premier biopharmaceutical companies, as a key member of the Global Pharmaceuticals Communications team. The role is dedicated to managing day-to-day… more
- Merck & Co. (Rahway, NJ)
- …chain efficiencies, and improve product stewardship practices, while ensuring compliance with regulatory requirements.6. Foster a culture of excellence, ... and materials characterization tools and techniquesExtensive knowledge of technical and global regulatory requirements for medical devices and combination… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Respiratory will focus on driving strategy, development, and life-cycle ... plans from the ground up. They will also be responsible for guiding Product Development Team Leaders and Clinical Directors within their group to ensure that… more
- Merck & Co. (Rahway, NJ)
- … product manufacturing processes to GMP production facilities.Experience authoring regulatory filings, and demonstrated working knowledge of FDA, ICH, and other ... influencing regulatory strategies and a track record of supporting global filings is highly desired.Experience on a large capital project team, knowledgeable… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …audits and independent audits; manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one...OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of autologous… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic ... new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling… more
- Merck & Co. (Durham, NC)
- …and new product license registrationsCollaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirementsInfluence, motivate, and ... Manager will be responsible for activities that support cGMP and regulatory compliance during facility design, construction, start-up method transfer/validation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/ Global Pharmacovigilance (PV) ... and tracks regulatory trends, legislative changes, and guidelines issued by global regulatory agencies (FDA, EMA, MHRA, etc.) related to CSPV. Participates… more
- Merck & Co. (Durham, NC)
- …will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product testing to include ... and new product license registrationsCollaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirementsInfluence, motivate, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic ... new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling… more
- Merck & Co. (Durham, NC)
- …meet established delivery timelinesProvide active support during audits and inspections ( regulatory , internal, safety)Collaborate with site compliance team to ... responsibility. IMPACT: InfluenceRepresents Quality in the laboratory to influence cGMP compliance and ensure product quality.Explains difficult issues and… more
- Merck & Co. (Rahway, NJ)
- …software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product development to ... Job DescriptionOur company is a global health care leader with a diversified portfolio...technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …existing CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/ Regulatory compliance across CMR functions. Position will serve ... execution, maintenance of technical training across all CMR functions, and compliance across clinical development, medical, and regulatory roles/processes/SOPs… more
- Merck & Co. (Rockville, MD)
- …plan that advances business goals.The SRP team comprises of four contributing teams: Global Regulatory Policy (GRP)Data & Advanced Digital Technology Policy ... the development and implementation of clinical research policy goals.Working closely with the Global Regulatory Policy team to align on clinical research policy… more
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