- Novo Nordisk Inc. (Plainsboro, NJ)
- …outcomes, identify market opportunities, address regulatory requirements, and shape product development strategies Regulatory Compliance : Ensure early ... (TPP) Development: Provide strategic input and support for clinical trial strategy, regulatory development, and the development of Target Product Profiles (TPPs)… more
- Merck & Co. (Rahway, NJ)
- …of strategies for device technology selection, clinical evaluation, early combination product development, and regulatory compliance . Position Qualifications ... and coordinating diverse activities between various device and combination product development, discovery, and formulation development teams.This involves managing a… more
- Merck & Co. (North Wales, PA)
- …for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises ... provide recommendations to Regulatory CMC leadership team as appropriate.Provide regulatory leadership as needed in product in-license/due diligence review, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This ... and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU SmPC, PIL,… more
- Merck & Co. (Durham, NC)
- …will ensure optimized product quality and manufacturing processes, regulatory compliance , employee and environmental safety, integration of new/existing ... QNs pulled for audits/inspectionsResponsible for oversight and project management of regulatory filing preparedness in the Fermentation area - including interactions… more
- Merck & Co. (North Wales, PA)
- …modern operating excellence.-The IT Director of the Content & Promotional Lifecycle Automation Product Line is a key leadership role in the Customer Engagement & ... content to the markets.This role will be leading a product line of agile product teams that...launch planning, content creation, digital asset management, medical legal regulatory review capabilities to our brand strategy and marketing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relevant vendors. Internal stakeholders: Global Safety, QPPV office, Global Development, Product Supply, Regulatory Affairs (NNI/NNCI) marketing, legal and NNI ... processes and activities are compliant with NAO regulations and NAO regulatory authority and inspectors' expectations; Ensure compliance with applicable… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Sr. Product Manager (SPM), US Oncology Women's Cancer, is responsible for contributing to the strategic ... is responsible for designing, implementing and evaluating the marketing activities of assigned product (s) within a given product line; participates in the review… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role OverviewThe Quality Compliance - Lead Auditor CAR-T is responsible for regulatory compliance supporting the production of autologous CAR-T products for ... and independent audits; manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements through… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) ... tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Program Leadership and Technical ... performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance:Ensure that all activities are… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 compliance teams to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents ... ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes… more
- Merck & Co. (Rahway, NJ)
- …statistician in cross-functional teams for the strategic planning and execution for product development and worldwide regulatory submissions.Lead a team of ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Tris Pharma (Monmouth Junction, NJ)
- …capabilities, when needed. The incumbent ensures timeline, quality and compliance with applicable Standard Operating Procedures (SOPs)/current Good Manufacturing ... priorities. She/he also reviews and approves all scientific, technical and regulatory packages per International Council for Harmonization (ICH)/Food and Drug… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in understanding and implementing Digital Health and Connected Care strategies Regulatory and Compliance Alignment: Ensure that digital health initiatives ... support implementation and execution of digital initiatives Digital Health Product Execution: Drive the development and implementation of digital...align with regulatory requirements and compliance standards in the… more
- Merck & Co. (Rahway, NJ)
- …software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product development to ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Strategy, Insights and Analytics, IT, Data Strategy, Commercial Excellence, Legal, Compliance , Privacy, Regulatory Affairs, and other relevant NNI departments ... with broader TA and asset plans Work collaboratively with medical, market access, regulatory , legal, compliance , privacy and public affairs functions to support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Annual Product Review as per internal procedures and current regulatory requirements tracking all the complaints, deviations and change control related with ... for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesHelps improve metric ... PLCs, VFDs and electrical practices generally attained through hands-on experience, cGMP compliance , EHS and regulatory standards (eg EPA, OSHA and… more
