- 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)
- …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)
- …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)
- …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
- 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
- Haleon (Warren, NJ)
- …In line with a risk-proportionate framework for product vigilance, the **Associate Director , Consumer Safety Science** is accountable for developing the ... safety issues related to product defects at manufacturing sites. + Provide safety expertise into regulatory documents and responses to boards of health. +… more
- American Water (Short Hills, NJ)
- …seeking a water quality leader to join and help lead our operations. The* Director of Water Quality & Environmental Compliance* will be the point person for ... quality assurance programs. * Knowledge of government regulations related to water quality and employee/community safety . * Knowledge of current and emerging… more
- Bristol Myers Squibb (Madison, NJ)
- … requirements, and driving strategic initiatives to enhance safety science processes. **Duties/Responsibilities** **General Product Scientific Support** + ... maintain external relationships with thought leaders and companies. + Represent BMS safety science interests in external groups ( regulatory bodies and… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …of our clinical development programs, ensuring they meet the highest scientific and regulatory standards. The Senior Director will also play a key leadership ... Job Title Senior Director , Clinical Development & Medical Affairs (CDMA) Requisition...aspects of registration activities with a working knowledge of regulatory affairs, in the development of the project strategy… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …commercial, regulatory , pharmacovigilance, manufacturing, and pre-clinical development. The Senior Director will serve as a clinical leader for INDs, NDAs, BLAs, ... Senior Director Clinical Development - Psychiatry Date: Jan 28,...Proactively identify and mitigate risks across clinical programs, ensuring quality and compliance with all regulatory requirements.… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Senior Director , Clinical Development will ... Senior Director Clinical Development - Respiratory Date: Jan 21,...working closely with other functional areas such as commercial, regulatory , pharmacovigilance, CMC, early clinical and pre-clinical development in… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …This role supports the shaping of the global strategic direction of the Quality Audit program to assure compliance with regulatory requirements across Research ... and assuring effectiveness in delivery on quality objectives and a strong quality voice. Additionally, the Senior Director will collaborate closely with the… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …the Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate and ... We are seeking an Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development,… more
- Sunrise Senior Living (Basking Ridge, NJ)
- …team member relations and recognition, communication, family services, resident well-being, quality assurance, and regulatory compliance. Additionally, a key ... residents to competitors, with a declining trend that is below company average. Quality Assurance and Regulatory Compliance: + Strives for excellent quality… more
