- 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
- 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
- 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. (Upper Gwynedd, PA)
- …Next Generation Sequencing (NGS), Professional Networking, Project Management, Regulatory Affairs Compliance {+ 3 more}-Preferred Skills:Job Posting End ... where relevant, DP) development teams for various assets/biomarkers (including Regulatory , Commercial, Business Development, Project Management, Operations, Clinical Development,… 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)
- …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
- 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. (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
- 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. (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
- 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
- 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
- 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
- Eisai, Inc (Nutley, NJ)
- …products, compliance statements, audit certifications, and safety issues for regulatory submission. May use six-sigma methodology. May provide training on GCP ... accuracy and quality of scientific data submitted to the regulatory agencies in support of new drug application, biological...within the Global Clinical Quality team to conduct GCP compliance activities at Eisai, at our CROs and Investigator… 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
- Genmab (NJ)
- …providing SDTM mapping guidanceEnsures study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study ... the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards and other industry standards that supports the exchange… more
- Legend Biotech USA, Inc. (Minneapolis, MN)
- …Sr. CTCE is responsible for conducting all activities in accordance with current regulatory and health care compliance guidelines and in alignment with the ... operating company labeled scientific data; market dynamics and competitive landscape; regulatory and health care compliance guidelines; corporate policies on… 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
- Merck & Co. (Durham, NC)
- …- Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing ... establishing a strong business partnership and ensuring excellence in Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director,… more
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