- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- … agencies. Supervise designated personnel. Relationships Report to the Director/Associate Director/ Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. ... assure accurate and complete documents for inclusion in these applications Review of regulatory strategy documents; eg, provides supervisor with input on … 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. (North Wales, PA)
- … the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. Lead development and execution of ... Scientist will lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist and Assoc… more
- Merck & Co. (Rahway, NJ)
- …limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead .Develops worldwide product regulatory strategy to optimize label ... growth mindset. The Director, Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their assigned products, in order to optimize… more
- Merck & Co. (Rahway, NJ)
- …Next) or other strategic frameworksGlobal experienceKnowledge of Company commercial, regulatory , and legal compliance policiesNOTICE FOR INTERNAL APPLICANTSIn ... to GRL Support development and execution of portfolio roll-out and migration strategy Manage planning and execution of tumor-team pilots and deployment of other… 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
- Eisai, Inc (Nutley, NJ)
- …management/senior leadership. Continuously update plans and inform stakeholders of progress.She/He will lead medical strategy mainly for GU oncology and provide ... from you.The Sr Medical Director provides medical leadership for medical affairs strategy , planning and supportive tactics mainly for GU therapeutic area. This role… 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …play a critical role in partnering with other NNI teams to drive health systems strategy Regulatory and Compliance Alignment: Ensure that all aspects of the ... diagnostic and precision health strategy align with regulatory requirements and compliance standards. Collaborate with regulatory affairs and … more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Contracting & Distribution Strategy (C&DS) Field Execution role plays a critical leadership role in the development of contracting confidence and- ... Account Management , Learning and Development, Clinical Review Teams, Legal and Compliance . In addition, this individual will work closely with the Promotional… more
- Aequor (Seattle, WA)
- …Product Team Lead and Stewards to enable effective execution of strategy and plans. Compile and efficiently manage process data from various data owners ... Job Title: The Data Stewardship and Compliance Business Analyst Location: Seattle-Dexter, WA*Hybrid Top Skills:...MS&T cell therapy to compile and ready data for regulatory filings and to support validation activities. This position… 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
- 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)
- …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
- Merck & Co. (Rahway, NJ)
- …to ensure GRACS contractual obligations and commitments are met while maintaining regulatory compliance .Work closely with the Corporate Business Development, our ... Diversity and Inclusion principles.Desired Experience: Experience with Alliance Management and/or Regulatory strategy and process for partnerships (multiple deal… more
- Insmed Incorporated (Bridgewater, NJ)
- …management regarding the potential impact of toxicology results on Program and Clinical/ Regulatory strategy . Author nonclinical sections in regulatory ... different therapeutic areas, ensuring alignment with company objectives and in compliance with regulatory guidelines and industry standards. Provide scientific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …consistent brand/therapeutic area vision and message.RelationshipsReports to HCP / KOL Strategy Lead . Collaborates with cross-functional teams, including sales, ... market dynamics, especially within specified therapy area preferredStrong understanding of regulatory , compliance , and ethical considerations in engaging with… 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
