- Merck & Co. (Rahway, NJ)
- …recurrence. Identify and design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team and End ... Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Labeling,… more
- Merck & Co. (Upper Gwynedd, PA)
- …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... through product development including assessment of the probability of regulatory success together with risk mitigation measures.-Lead...Process Development, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory … more
- Merck & Co. (Rahway, NJ)
- …and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine ... activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... momentum, and an inspiring mission to achieve new milestones in global healthcare . The Biologics and Biopharmaceutics team is responsible for the research and… more
- Merck & Co. (Rahway, NJ)
- …development and lifecycle management, ensuring compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive ... in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership and Project… more
- Merck & Co. (Durham, NC)
- …Multi-Management, People Leadership, Physical Sciences, Production Management, Project Management, Regulatory Compliance {+ 2 more}-Preferred Skills:Job Posting ... North Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards, policies, and procedures… more
- Merck & Co. (Durham, NC)
- …process understanding Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments Author ... and Instrumentation Diagrams Lean Six Sigma belt certification Experience with process risk assessment tools Experience with responding to regulatory questions… more
- Merck & Co. (Rahway, NJ)
- …functions including Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs, as well as, the GBO Leadership Team (LT). This role ... the SVP and executive team with clear line of sight into launch risk , site readiness and required interventionsDrive implementation of best practices in NPI… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… more
- Merck & Co. (North Wales, PA)
- …Risks, Life Science, Medical Writing, Motivation Management, Prioritization, Project Management, Regulatory Compliance , Regulatory Documents, Science {+ 4 ... reports, study close out activities).Leads team for timeline management, risk identification and mitigation, issue resolution.May facilitate and collaborate with… more
- Merck & Co. (Rahway, NJ)
- …Process Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and ... as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies… more
- Merck & Co. (Rahway, NJ)
- …candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This ... will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices (cGMPs), and participating… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP/Document Audits supports end-to-end audit activities per audit program of ... GxP group and its partners as applicable ensuring the execution of a risk -based audit program and effective CAPA management resulting from audits, health authority… more
- Merck & Co. (Rahway, NJ)
- …Skills, Procurement, Procurement Management, Production Planning, Project Procurement Management, Regulatory Compliance , Risk Management, Stakeholder ... strategy in line with the global strategy, including supplier management, compliance , risk management, diversity spend, and stakeholder management.Monitor key… more
- Merck & Co. (Rahway, NJ)
- …. - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply related ... products and non-our company marketed products . - Analyzes and anticipates project risk s as they relate to clinical supply chain deliverables and prepares ,… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream processes by increasing ... prioritization, and problem-solving skills.Stay updated on the scientific and regulatory landscape; contribute scientifically and build your reputation through… more
- Merck & Co. (Rahway, NJ)
- …The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering ... Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our… more
- Eisai, Inc (Nutley, NJ)
- …Influence, Critical Thinking & Business Agility, Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management, Legal Knowledge, ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that all content, community interactions, and account activities comply with legal, regulatory , and corporate standards.- Collaborate with legal, compliance , and ... guidance to internal teams and regional stakeholders on best practices, compliance , and content management.- Develop and maintain an enterprise messaging strategy… more
- Merck & Co. (Rahway, NJ)
- …development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising, ... network internally and will advance a culture of scientific excellence and compliance with our company's procedures for recording time, data entry, and trainings.… more
