- Merck & Co. (North Wales, PA)
- Job DescriptionOur Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, and ... compliant drug/diagnostic regulatory strategies and approaches across geographies.Under direction of the Executive Director, Companion Diagnostics/In Vitro… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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) to address labeling issues… more
- Merck & Co. (North Wales, PA)
- …and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional ... practices are consistent with regulatory guidelines, our company's policies, and support business objectives.Serve as the liaison and manages correspondence with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Windstream (Columbus, OH)
- …Performance/Working Environment: Computer, Printer, Telephone, Cellular Phone Type of Driver's License Required: Driver's License Our Benefits: Medical, Dental, ... Commission, is required to notify and to obtain approval from federal regulatory agencies prior to granting certain system/network access to any non-U.S. citizen… more
- Windstream (Columbus, OH)
- …Dust: Occasionally: 0-33% | Fumes/Gases: Occasionally: 0-33% Types of Driver's License Required: Driver's License Our Benefits: Medical, Dental, Vision ... Commission, is required to notify and to obtain approval from federal regulatory agencies prior to granting certain system/network access to any non-U.S. citizen… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is ... those functions. Prepares legal documents such as contracts, correspondence (eg, to regulatory agencies), both independently and for review, approval, and use by… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... projects in Late Development Statistics.Lead the interaction with Clinical, Regulatory , Statistical Programming, Data Management, and other Company Research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation ... of developmental and regulatory strategy; Drafts protocol profiles and sections of key...in Business Development activities for late-stage compounds Involvement with in- licensing and acquisitions on individual due diligence activities; Contributor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation ... of developmental and regulatory strategy; Drafts protocol profiles and sections of key...Business Development activities for late stage compounds Involvement with in- licensing and acquisitions on individual due diligence activities; Contributor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Bar Admission in NJ (direct admission or eligible for limited in-house licensing in NJ.) required Experience Qualifications- 7 or More Years of post-law school ... experience required- 7 or More Years experience in regulatory , compliance, and legal matters relating to pricing and...New Jersey (either licensed in NJ or limited in-house license ) and maintain such license in good… more
- Merck & Co. (North Wales, PA)
- …development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international ... or marketed vaccines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerationsPlanning clinical… 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 ... related drug/vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory , Statistical Programming, Data Management, and other company Research… more
- Merck & Co. (Rahway, NJ)
- …biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory ... team environment with key stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure timebound… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... KOL interactions on a program based need; Involvement with in- licensing and acquisitions on individual due diligence activitiesQualifications: Successful candidates… more
- Merck & Co. (Rahway, NJ)
- …formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products ... product technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Rahway, NJ)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... reporting and interpretation of dataMaintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents… more
- Tris Pharma (Monmouth Junction, NJ)
- …with all Tris functions that contribute to the partnership, including R&D, Regulatory , CMC, Finance, Legal, and more. Understand their roles, their strategic ... Support Business Development. Support expanding existing partnerships or other out- licensing projects, particularly ones similar to our current alliances. Leverage… more
- Merck & Co. (Rahway, NJ)
- …packaging, compatibility characterization for processing and administration, and supporting regulatory filings. Have deep fundamental knowledge around large molecule ... development to ensure completion of key milestones and laboratory / regulatory documentation. Active strategic and technical leadership on program development teams,… more
- Merck & Co. (Rahway, NJ)
- …work closely with other analytical groups in ARD , Global Quality and Regulatory Affairs-CMC to ensure that validated methods are appropriately transferred from our ... issue management and mitigation plan developmentSupport subject matter experts and regulatory colleagues in authoring of relevant regulatory submission… more
