- Repligen (Waltham, MA)
- …desirable.Experience:A minimum of 10 years of progressive experience in internal controls, SOX compliance , or related regulatory compliance roles within a ... OverviewRepligen Corporation is seeking a dynamic Controls & SOX Compliance leader. This is a high-impact, strategic role driving global compliance ,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a skilled privacy professional to help drive our privacy strategy, implement our global privacy program, ensure compliance with ... other team drives program governance and privacy operations, supporting privacy compliance through the development and maintenance of program strategy, processes,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and guidance to RD PV QA on quality assurance practices and regulatory compliance .Keep abreast of evolving regulations and industry standards concerning ... and Quality OversightPlay a key role in ensuring compliance with regulatory requirements while driving innovative...preferred. Basic QualificationsMust have 10 or more years of professional experience in Quality, IT compliance and… more
- Merck & Co. (Rahway, NJ)
- …Process Improvements, Project Information Management, Project Management, Project Planning, Regulatory Compliance , SAS Macros, Social Collaboration, Software ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Lower Gwynedd, PA)
- … Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance , Regulatory Experience, ... of company business developed through education or experience.Understands and applies regulatory / compliance requirements relative to their role.A problem… more
- Merck & Co. (Durham, NC)
- …a quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing ... standard operating procedures that impact the efficiency and effectiveness of own unit. Compliance - Creating and sustaining a culture that ensures that compliance… more
- Merck & Co. (Rahway, NJ)
- …Leadership Mentoring, Pharmaceutical Process Development, Professional Collaboration, Professional Networking, Quality by Design, Regulatory Filings, Social ... different stages of clinical development, 2) process characterization and regulatory filings for successful commercializationAdvance upstream processes by improving… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety and PharmacovigilanceR&DVendors/ CROs/ third partiesHEOR/ RWEEpidemiology Legal and compliance Marketing/ commercialGMP QA/ Supply chain / Regulatory ... for specialty pharmacy, REMS, co-partners and affiliates. Liaise with Audit and Compliance team to ensure that Global Medical Affairs audits are properly planned,… more
- Merck & Co. (Boston, MA)
- …tumor size and survival. A Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring ... regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs), and representing QP2-IO at regulatory … more
- Eisai, Inc (Raleigh, NC)
- …to Eisai.Ability to provide strategic vision to organization around increasing compliance and reducing costs.Experience developing and leading professional staff ... SCM Unit will lead a cross-functional team driving excellence in Import/Export Compliance , Logistics, and Supply Chain support while interfacing closely with other… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data and external data, CDASH/SDTM, industry best practices, and relevant regulatory requirements is essential. This position demands significant skills in working ... Validation and Reporting staff. Directs programming representation in audits and regulatory inspections to provide relevant programming and reporting information as… 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 incumbant is responsible… more
- Merck & Co. (North Wales, PA)
- …analyses on programs. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics (monoclonal antibodies, antibody ... drug conjugates, T-cell engagers, bispecifics) in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical… more
- Merck & Co. (San Francisco, CA)
- …proportional hazards models. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring ... regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),...Proficiency in R, NONMEM or other similar programing language. Professional working proficiency in written and verbal communication. #EligibleforERP#QP2Current… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …brand marketing, market access, commercial effectiveness, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... Brand Marketing, Training, Commercial Insights and Analytics, Managed Markets, Legal, Compliance , and Finance. The position has high exposure to senior management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …brand marketing, market access, commercial effectiveness, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... relations with patient/caregiver consultants and, key opinion leaders (KOLs), professional organizations, customers and patient support service providers and… more
- Aequor (Thousand Oaks, CA)
- …of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting ... Standard business hours You've worked hard to become the professional you are today and are now ready to...leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance … more
- Merck & Co. (Rahway, NJ)
- …Within QP2, you have a uniq ue oppor t unity to accelerate your professional career as a quantitative drug developer taking advantage of our end-to-end pipeline ... external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and… more
- Lundbeck (Memphis, TN)
- …issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Apply knowledge of pharmaceutical and regulatory ... Memphis, TN SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that...growth! We are seeking a dynamic and results-driven sales professional with a proven track record of success who… more
