- Merck & Co. (Rahway, NJ)
- …Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary ... Job DescriptionOur Regulatory Affairs team bring new medical... regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategies, activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, ... is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through...preferred Experience Qualifications7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years… more
- Tris Pharma (Monmouth Junction, NJ)
- …The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs , Manufacturing, Quality, etc. to identify, evaluate ... individual case reviews, assessment of expectedness and relatedness; Collaborates closely with Regulatory Affairs or appropriate vendors on expedited reports, as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA...SC and biologics, Corporate Business Management)Partner and collaborate with global marketing, global medical affairs ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etcQualifications: Successful candidates will be able ... new medicines to help peopleUnder the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs , HEOR and other stakeholders to ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Piper Companies (Philadelphia, PA)
- …degree with 3+ years pharmaceutical/biotech industry experience including 2+ years regulatory affairs or regulatory operations experience. Experience ... regulatory submissions and managing document authoring and review workflows. Global Regulatory submission experience Detail-oriented with expertise in FDA… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …cross-functional teams, including clinical pharmacology, translational medicine, clinical operations, medical affairs , regulatory affairs , and commercial, to ... compliance with regulatory requirements and guidelines, working closely with regulatory affairs to facilitate timely submissions and approvals.Clinical Trial… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …and non-GLP) at external CROs per Jazz standards and ensures that global regulatory /compliance requirements are met/exceeded.Critically reviews and edits CRO ... CROs upon internal review and team communication, ensuring consistency with global regulatory and compliance requirements.Provides critical input on discovery… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …apply via the Internal Career siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives ... that comprise the data and analytics platforms used by the Jazz Global Clinical Development Operations (GCDO) department. The two platforms currently are:A SaaS… more
- AbbVie (North Chicago, IL)
- … and Medical Affairs Quality Standards is responsible for the management of a RDQA global Safety , Regulatory Affairs (RA) and Medical Affairs ... relating to R&D business stakeholders including but not limited to Pharmacovigilance and Patient Safety , Regulatory Affairs and Medical Affairs to ensure… more
- Microsoft Corporation (Redmond, WA)
- …will report to Microsoft's Corporate Vice President for Global Privacy, Safety and Regulatory Affairs . **Responsibilities** **Strategic Planning and ... lives of people all around the world. The Privacy, Safety and Regulatory Affairs (PSRA)...public's trust by adapting to heightened expectations and expanded global regulation. The General Manager for Regulatory … more
- Merck (Rockville, MD)
- …Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... **Job Description** Our Regulatory Affairs team bring new medical... regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or… more
- Amgen (Washington, DC)
- …legal support of Amgen's Global Development organization, as well as Global Regulatory Affairs , Patient Safety , Medical Affairs , R&D Quality and ... one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products… more
