- Novo Nordisk Inc. (Plainsboro, NJ)
- … Affairs labeling related issues. Relationships Reports to labeling management in Regulatory Operations and Innovation. Develop and maintain positive rapport and ... on cross-functional teams focused on the planning and execution of regulatory labeling operations . This includes anticipating labeling obstacles, identifying… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Rahway, NJ)
- …CMC.- Strong understanding of integration and partnering with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areas.Demonstrated ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Value process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums ... of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard… more
- Novo Nordisk Inc. (Boulder, CO)
- …support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at ... the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Tris Pharma (Monmouth Junction, NJ)
- …between marketing and other cross-functional teams (ie, Medical Affairs, Sales, Regulatory Affairs, Operations , etc.)Collaborates closely with Analytics team to ... and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, oversees implementation, and monitors adherence… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations , the Associate Director (AD) is responsible for ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Insmed Incorporated (San Diego, CA)
- …CRS will provide clinical and scientific support to clinical development and operations , regulatory , medical affairs, drug safety, and quality assurance teams, ... scientific review of information to support the development and updates for regulatory documents (ie, IND submissions, IND Annual Updates, DSUR, and Investigator… more
- Insmed Incorporated (San Diego, CA)
- …clinical development team, partnering closely with heads of clinical operations , toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality, ... & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data.… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …process qualification, packaging and labeling. This position will interface with Operations , Regulatory , Quality Assurance, Finance, R&D, Project Management and ... monitoring for new products and processes to be included in regulatory submissions.Coordinate and communicate with cross function team members throughout Exela… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead actively engages… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within and across line functions, eg Clinical Development, Medical Affairs, Regulatory Affairs, Clinical Operations . Formulates strategic approaches for risk ... with key high-level internal and external stakeholders and approves regulatory reports/submissions using expert safety knowledge.This position independently addresses… more
- Merck & Co. (Lower Gwynedd, PA)
- Job DescriptionAbout Us: The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and… 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...and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling… more
- Genmab (Plainsboro, NJ)
- …providers.The focus of this role will include stakeholders in the business domains Field Operations , Medical & Regulatory Affairs and US and Japan Market and ... and Genmab Security Operations TeamBusiness leaders (eg, VP Medical Affairs, VP Regulatory Affairs, GM Genmab US, IT Lead in Japan)Peers within IT&D, such as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project management in cross-functional drug development teams or clinical, regulatory , pharmaceutical sciences/technical operations in the biopharmaceutical ... Biotech is seeking Senior Project Manager, PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible for… more
- Genmab (Plainsboro, NJ)
- …informatics, Research data products, Lab systems automation, Development Operations , Pharmacovigilance, Regulatory , integration and Data visualization.At ... to harness the power of AI, driving digital transformation across our operations . We are looking for an innovation-centric Technical Solution Architect (R&D), who… more
- Merck & Co. (Millsboro, DE)
- …a Bio-Technology Center of Excellence that performs vaccine production operations from antigen production through formulation, filling and packaging.-With expertise ... departments Review and revise processes and procedures against corporate and regulatory requirements to insure compliance Review production records for completeness… more
- Aequor (Waltham, MA)
- Job Title: GMU CMC Operations LeadLocation: Waltham, MADepartment: Genomic Medicine Unit CMCShift: 1st Work Schedule: Mon-Fri 8:00 am - 4:00 pm ESTDescription:About ... (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval. Our mission is to… more
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