- Merck & Co. (Rahway, NJ)
- …and project delivery.A complete understanding of ICH GCP and Global /Regional/Local regulatory requirements is required.Strong Communication skills requiring ... Job DescriptionThe Executive Director (ED) is the Clinical Operations lead in...scope for GCTO country operations.Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity ( Global R&D & PV QA) ensures high ... solutions, integrates AI technologies, and drives process improvements. Collaborating with the Global QMS eCompliance team, the director oversees QA plans,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partner side) CDx RA Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these ... procedures.Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and...issues, and risks in written and verbal format to regulatory senior leadership team and other governing… more
- Eisai, Inc (Nutley, NJ)
- …industry preferred.Skills:Eisai Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs - Neurology is from ... want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and... Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... clinical, and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …but not limited to - Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues, to deliver data-driven ... Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Associate Director - Launch Excellence will guide launch planning and execution at NNI - for the ... to business growth and success. Relationships Reports to Executive Director Launch Excellence. Collaborates with cross-functional teams, including, brand marketing,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Associate Director - Launch Operations will play a pivotal role in managing the launch process ... to business growth and success. Relationships Reports to Executive Director Launch Excellence. Collaborates with cross-functional teams, including brand marketing,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...resources for key programs. The role will also provide senior safety leadership and guidance on complex issues across… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, a Senior Principal Scientist/ Senior Director , has primary responsibility for developing ... development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions.… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionOur company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the strategic roadmap for US Operations, involving extensive collaboration with senior US Operations and Global stakeholders. Additionally, this position ... plans to drive growth and longer-term value. Close collaboration with the Director of Enterprise Strategy Activation is essential to ensure strategic shifts and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …organization. It also plays a pivotal role in coordinating local activities with global monitoring functions, in support of Novo Nordisk's overarching global ... ethics and compliance program. Relationships Reports to the Executive Director , Risk Insights & Management. Manages a team of compliance professionals focusing on… more
- Merck & Co. (Rahway, NJ)
- …to ensure compliance and reduction in workplace Industrial Hygiene risks.Lead global continuous improvement initiatives to improve global Industrial Hygiene ... the globe.Identify, interpret and perform impact analysis on emerging global industrial hygiene regulations, guidelines and consensus standardsAudit Industrial… more
- Novo Nordisk Inc. (WA)
- …locally and globally. Relationships Reports to the Market Access and Public Affairs Senior Director , Policy. Other internal relationships include a dotted line ... potential? This role can sit in Plainsboro, NJ or Washington, DC. The Position The Director - US Tax, Trade, IP works on complex issues that will require an in-depth… more
- Repligen (Waltham, MA)
- …& SOX Compliance leader. This is a high-impact, strategic role driving global compliance, strengthening internal controls, and leading the SOX program. Shape and ... execute compliance strategy across a global company Lead SOX risk assessments, audits, and remediation...SOX risk assessments, audits, and remediation efforts Partner with senior leaders to embed strong controls into business processes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Director Channel Strategy & Planning will play a critical role in shaping the future ... teams in NNI (including MAPA), including marketing, medical, R&D, regulatory affairs, finance, NNGlobal, and other relevant entities to...Leadership Decision Support o Provide one unified NNI and global voice and point of voice to leadership to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent, ... ultimately negotiated with PBM/payer customers. Relationships Reports to the Executive Director , Strategic Pricing & Contracting. Responsible for leading a team of… more
