- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …any time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submissions globally. The Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited to ... areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory ...and Regulatory operations required.4 or More Years regulatory affairs including filing NDA and sNDA.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the CSPV and key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports...with internal and external stakeholdersInteract with senior CSPV/ Medical Affairs leadership teams to ensure Quality is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …drive organizational action, guide the Business units and the Clinical, Medical, and Regulatory Affairs (CMR) teams on strategy development and execution. This ... Are you ready to maximize your potential with us? The Position The Director , CMR Insights Lead is responsible for leading the generation, integration and translation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functional project teams, including Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs personnel to manage preparation of the ... written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director...This role will be a senior member of the Regulatory , Quality and Clinical Reporting (RQC) team,… more
- Insmed Incorporated (Bridgewater, NJ)
- …legal, regulatory reviewWith Medical Excellence, lead training of Medical Affairs teams on new materials and upcoming educational activitiesEnsure delivery of ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Scientific Communications is a core member of Medical Strategy and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... point of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan,… more
- Tris Pharma (Monmouth Junction, NJ)
- …conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs , Product Development, Research and Development (R&D), Quality Assurance ... Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal ... Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior ... driving Business Development decisions in collaboration with External Scientific Affairs dept.Responsibilities- Clinical Monitoring Planning : Oversees and coordinates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities related to Medical ... and select medical material) is of the highest scientific quality and is compliant with all relevant policies, procedures,...and is also an integral member of the Medical Affairs Team. This position plays a key role in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , ... users to define user information needs.Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver… 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 ... multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS)...CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs , and Regulatory Affairs (CMR), staying up-to-date ... the CMR training strategy Ensuring CMR employees receive training on regulatory compliance, quality standards, GxP requirements and industry-specific guidelines… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etcQualifications: Successful candidates will be able ... related to study, project and submissionManage CRO to ensure high quality compound and multi-compound level deliverablesLead the development of global harmonization… 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 ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The position may also ... statistical results and provide input on reporting (CSR) to support Medical Affairs and HEOR/HTA strategies: Plan, set-up and execute additional statistical analyses… more
