- Merck & Co. (North Wales, PA)
- …safety to ensure that PV processes are integrated into the overall product development plan.-Communicate PV information to internal and external stakeholders, ... team at our Company's R&D division (our Research & Development Division ) is looking for Product ...the company's PV processes and systems comply with these regulations .-Ensure compliance with regulations : Responsible… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the FDA to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all ... sponsorships, Investigator Sponsored Studies (ISS) and supplier service agreements Ensures compliance with government rules and regulations relating to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and ... deviation requests for Daiichi Sankyo and partner companies, if applicable.Ensure Compliance with Labeling Regulations and Guidances: Demonstrate expert… more
- Merck & Co. (Rahway, NJ)
- …spearhead regulatory activities for Devices and Drug-Device Combinations (DDDC), ensuring compliance with domestic and international regulations and guidance. ... device and combination products, guiding cross-functional teams to ensure regulatory compliance throughout development and commercialization. Mentor team members… more
- Merck & Co. (Rahway, NJ)
- …with subject-matter experts on the DPPD team and members of internal cross-functional product development teams from concept through product launch.- ... to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead and set direction… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …direction and initiatives within the TA. This role is responsible for guiding product development and commercialization strategies for late stage and in-line ... portfolio. The mandate of STARS is to facilitate the development and to coordinate the execution of the long-term...report based on position, skills, talents, and objectives Ensures compliance regulations are understood and adhered to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and ... deviation requests for Daiichi Sankyo and partner companies, if applicable.Ensure Compliance with Labeling Regulations and Guidances: Demonstrate expert… more
- Merck & Co. (New York, NY)
- …assigned geography. Compliance and Ethical Promotion: Demonstrate commitment to compliance with regulations , industry codes, and company policies governing ... your primary objectives will be to contribute to the development of our presence among thought leaders, engage in...and adhere to reporting requirements.Stay informed about changes in regulations and compliance guidelines relevant to the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the FDA to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all ... execution, maintenance of technical training across all CMR functions, and compliance across clinical development , medical, and regulatory roles/processes/SOPs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the FDA to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all ... make a difference? The Position The Labeling Specialist supports the development of labeling activities for all regulatory submissions. This individual collaborates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health ... Authority labeling regulations for products and filings. Manages compliance with internal and external guidelines, reviewing US and EU package inserts with… more
- Tris Pharma (Monmouth Junction, NJ)
- …of clinical/medical data and information to ensure highest ethical standards and compliance with law, regulations , guidelines and policies Assists VP, Medical ... Researchers and Manufactures of America (PhRMA), etc.)Expertise in pharmaceutical compliance laws, regulations and guidelines related scientific communications,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …independent and maintains up-to-date knowledge of industry standards and regulatory compliance requirements and independently contributes to the development of ... a global supply of our hemophilia and growth hormone product lines, as well as our next generation of...and is required to supply support/technical knowledge for the development /refinement and implementation of the GEP program and validation… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with the manufacture of product Support in-process activities and product development when instructed by supervisor Incorporate pre-planned process ... a global supply of our hemophilia and growth hormone product lines, as well as our next generation of...adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. Work… more
- Taiho Oncology (Denver, CO)
- …evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower ... information on Taiho oncology products and services. The OAM will disseminate product , disease state, and fact statements about other products, across multiple… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the gap between scientific research and practical application in patient care Compliance and Regulations : Ensure all educational content and strategies comply ... in developing healthcare professional (HCP) education strategy and content development with a focus on our Obesity Business Unit....with pharmaceutical industry regulations and ethical guidelines, focusing on evidence-based information and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk's Rare Disease portfolio. The mandate of STARS is to facilitate the development and to coordinate the execution of the long-term strategy, defining a ... products in the pipeline, and products acquired through business development efforts in existing and new areas. The STARS...Hemophilia Therapy Area and for relevant in-line and new product commercialization assets (3 years prior to launch). They… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … development , manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of ... Summary:The Analytical Chemist I will provide analytical testing to support ongoing product release, raw material release and stability studies as needed, generate,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position ... Patient Safety, Quality, NNI IT and Telephony, Medical Information, Compliance , Regulatory, Legal and Privacy. External relationships include Patient Support… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. What ... and cultural change. Your role will be crucial in driving leadership development , especially among first-line leaders. By ensuring alignment with site and department… more
