- Merck & Co. (Rahway, NJ)
- …US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy .Providing quality advice to stakeholders ... an effective implementation and oversight model to maintain best-in-industry regulatory compliance .The Vice President Regulatory Affairs,… more
- Lundbeck (Bronx, NY)
- …Join us on our journey of growth!As a Neuroscience Account Manager, you lead the promotion of our psychiatry portfolio to Psychiatrist and Institutional Accounts ... use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress… more
- Merck & Co. (Rahway, NJ)
- …and implement robust SAP security policies, procedures, and controls.Ensure compliance with regulatory requirements and industry best practices.Manage ... the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all...They will also have responsibility for the end-to-end Upgrade strategy from roadmap to execution for the entire SAP… more
- Eisai, Inc (Nutley, NJ)
- …educating end-users on compliance requirements. Additionally, you manage regulatory compliance activities, maintain accurate documentation, and evaluate new ... crisis management.Manage IT training programs and conduct Segregation of Duties reviews. Regulatory Compliance Activities:Collaborate with legal and compliance… more
- Merck & Co. (Rahway, NJ)
- …are completed with the highest regard for safety, quality and regulatory compliance . Qualifications: Education Minimum Requirement: PhD and/or Post-doc ... both personally and through mentorship of others, and in driving the scientific strategy of the CBT group. The Senior Principal Scientist manages and prioritizes a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.Define data governance principles, policies, and ... as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory … more
- Merck & Co. (Rahway, NJ)
- …for non-sterile and sterile products.- It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality, and our ... formulation development.- In this position, the SMAR&D Director will set guidance, lead activities, and develop a team whose roles include the-development of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The HCP / KOL Strategy lead will be a pivotal driver in shaping an insights-driven HCP marketing ... objectives, KOL engagements, and strategies. The HCP / KOL strategy lead has a team of HCP...marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging… more
- Insmed Incorporated (Bridgewater, NJ)
- …brand's HCP Agency of Record.Work closely with cross-functional partners including Legal, Regulatory , Compliance , and Medical Affairs, to align and compliantly ... and Best Workplaces for Millennials™ lists.OverviewThe Associate Director, HCP Marketing, Branded Strategy & Execution will be a key member of the Bronchiectasis… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… 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 ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management and performance of CRO; Participates in creation of developmental and regulatory strategy ; Drafts protocol profiles and sections of key submission ... matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy : Clinical study leader (CSL) or major… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the Oncology and Specialty Medicine portfolios, in alignment with the business strategy . Lead the PV inspection management activities by ensuring readiness, ... preparedness for the respective PV inspections in alignment with regulatory and company strategy .Act as the management...that all functions consistently operate in a state of compliance .Facilitate the implementation of the quality strategy … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Marketing Orchestration: Lead the execution of the defined HCP marketing strategy and development of the HCP messaging/ promotional story. Ensure effective and ... About the Department Our Commercial Strategy and Marketing group creates and delivers human-centered...to experiment with us? The Position The HCP Experience Lead will play a critical role in ensuring the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with CRO senior leadership as needed; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts ... matters; Supports marketing in developing a commercial strategy include biomarker strategy ; Represents Clinical Development as Global Clinical Lead or as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and enforcement of data standards, demonstrated knowledge of industry standards related regulatory requirements (CDISC), FDA & ICH, PMDA, EU & ICH, CRP and ... processes. Working knowledge of early and late-stage submissions per local/ regulatory requirements, demonstrated ability to self-start, be solution-oriented with an… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliverables are met. The key responsibilities are within and for GCO to: 1) Lead and implement the establishment and oversight of an Inclusive Research and Patient ... Voice Strategy and Infrastructure, 2) Identify innovative approaches, industry best...in class diversity and patient voice planning, 3) Design, lead and implement the GCO delivery framework for diversity… more
- Insmed Incorporated (Bridgewater, NJ)
- …communicates about Insmed disease areas of interest and Insmed generated data. As the lead for global congress strategy in their assigned therapeutic area, the ... for content and positioning) and represent content during medical, legal, regulatory reviewWith Medical Excellence, lead training of Medical Affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accuracy and consistency of the coded data, and adherence to regulatory authorities' requirements.Ensure compliance with the protocol, external/internal ... delivery of medical coding for clinical trials, clinical development, and regulatory submissions. Develops and proposes strategies for medical coding and coding… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth… more
