- 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...party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... capture all communications via contact reports.Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. 15 E- Work with the business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical device ... medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …seasoned leader to strengthen and grow the Learning and Development program across the Regulatory - Safety - Quality (RSQ) function. In this role you will evolve ... and help create possible, together. **Job Description** The Central Quality Services team within R&D Quality is...program effectiveness + Foster and drive a culture of quality and continuous improvement across RSQ and Development **Change… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... via contact reports. + Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety ...all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly Reports) in paper and electronic format.… more
- Daiichi Sankyo Inc. (Basking Ridge, 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...party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company… more
- Actalent (Basking Ridge, NJ)
- …studies, post-marketing surveillance, signal detection, and regulatory submissions. The Director will ensure proactive safety monitoring through the ... Job Title: Director , Clinical SafetyJob Description The Director , Clinical Safety will be responsible for...+ Coordinate and manage resources to develop and deliver high- quality safety evaluation-related documents and deliverables on… more
- System One (Basking Ridge, NJ)
- …Effectively coordinate and manage available resources in developing and delivering high- quality safety evaluation related documents/deliverables on time. - ... Director Clinical Safety 12 month contract... Director Clinical Safety 12 month contract Hourly Pay Max: $100-...regulatory , but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of… more
- Sunrise Senior Living (Fairfield, NJ)
- …care. Perform skill evaluation to assure clinical capability of care team members. Quality Assurance and Regulatory Compliance: * Track, trend and report ... Sunrise of West Essex **Job ID** 2024-215730 **JOB OVERVIEW** The **Resident Care Director (RCD)/Nursing Director ** serves as the nursing clinical leader for the… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director , Clinical Development will provide ... global regulatory filings. **How you'll spend your day** The Director , Clinical Development will foster relationships with opinion leaders in assigned… more
- Sanofi Group (Bridgewater, NJ)
- …studies, and real-world evidence (RWE) studies. + Ensure the generation of high- quality , scientifically rigorous evidence to support the safety , efficacy, and ... **Job Title:** Medical Director - Global Medical Evidence Generation **Location:** Cambridge, MA **About the Job** We are an innovative global healthcare company,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Study Reports with minimal guidance and independently supports the development of regulatory documents; performs quality review and/or approval; adjudicates and ... The Director Clinical Sciences, Hematology, leads in the development,...team meetings, scientific advisory boards, study steering committees and data/ safety monitoring meetings; may represent function in collaborative activities… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV)… more
- Sunrise Senior Living (Basking Ridge, NJ)
- …NAME** Sunrise of Basking Ridge **Job ID** 2024-220603 **JOB OVERVIEW** The Associate Director of Sales (ADOS) is responsible for supporting and assisting the Sales ... duties the ADOS may, under the supervision of the Director of Sales (DOS), Director of Sales...resident's Administrative File according to Sunrise and state specific regulatory requirements. + Manages the move-in process as outlined… more
- Bristol Myers Squibb (Madison, NJ)
- …labels for marketed products). Compliance: Ensures MRSPs meet/exceed expectations for compliance, quality , regulatory and safety initiatives. Leads all ... training and oversight for the therapeutic area. Development/Processes: Deals with safety -related issues using critical medical and regulatory analytical… more
- Sanofi Group (Bridgewater, NJ)
- …electronic hardware, firmware and software, as well as the clear understanding of Quality and Regulatory requirements. + Strong understanding of regulatory ... ** Director of Connected Device Technology** **About the Job**...core device platforms and device manufacturing sites, Digital, Global Quality , GRA and other key functions in M&S organization.… more
- Bristol Myers Squibb (Madison, NJ)
- …of safety post-marketing commitments and ensuring compliance with global regulatory requirements. **Position Summary / Objective** The Head of Medical Safety ... training and oversight for the therapeutic area. Development/Processes: Deals with safety -related issues using critical medical and regulatory analytical… more
