- The Borgen Project is an innovative, national campaign that is working to make poverty a focus of U.S., Canadian and U.K. foreign policy. This is a part-time 12-hours per week, unpaid telecommuting internship. The internship is for 12 weeks, however, if your availability...HomeofficeTeilzeitarbeitRemote job
- ...formatting, and publishing of clinical documents required for regulatory submissions, and achieve rapid, accurate and timely submissions... ...(e.g., Regulatory Writing & Submissions, Regulatory Affairs, Trial Management, etc.) on the planning, preparation, and delivery...Soforteinstellung
- ...clinical development program(s) to support decision milestones, regulatory requirements and market access. The GCPH may contribute to... ...stakeholders (e.g., Research, Translational Medicine, Global Medical Affairs (GMA), Marketing, Health Economics & Outcomes Research), and...Remote jobInvalidenversicherung
- ...Monitor and analyze domestic and international timber markets to identify trends, supply-demand dynamics, pricing fluctuations, and regulatory changes that may impact trading activities. # Contract Negotiation: Negotiate sales agreements with clients, and intermediaries...
- ...should have: Deep Operational Expertise : Proven experience in Tech Ops – covering Lean manufacturing, supply chain, quality, regulatory, engineering,... and an impact mindset. Project Management Experience : 7+ years of experience driving strategic projects...Flexible Arbeitszeit
- ...in the assigned project or section of a clinical program • Leading development of clinical sections of trial and program level regulatory documents • Driving execution the assigned clinical program and/or clinical trial in partnership with global line functions, assigned...Invalidenversicherung
- ...operational effectiveness/innovation, especially in Drug Development ~ Excellent understanding of clinical development, quality and regulatory standards and policies ~ Well-established track record and sought after across the industry for strong Drug Development and...
- ...fleet management: be responsible for overseeing preventative maintenance/repairs and software updates in compliance with SOPs and regulatory requirements, and maintain logbooks in accordance with GCP standards. Write/edit/review SOPs for general instrument usage and...
- ...Record Keeping: Ensure proper documentation, tracking, and record-keeping of medical safety activities for assigned compounds. Regulatory and Professional Inquiries: Respond to inquiries from regulatory authorities or healthcare professionals regarding safety issues....
- ...manage and execute IP activities in the Commercial IP team, ensuring the highest quality and successful implementation of patent and regulatory exclusivity litigation strategies for commercial and later-stage development products. About the Role Key Responsibilities:...
- ...Experience in clinical Radioligand/Radiopharmaceutical Therapy (RLT/RPT) Experience in interactions with Health Authorities, Regulatory submissions, and Dosimetry Why Novartis: Helping people with disease and their families takes more than innovative science....
- ...timely resource allocation and ensuring critical medical capabilities within the big 4 (France, Italy, Spain & UK) countries Medical Affairs organizations. Leads performance optimization while maintaining governance oversight of Medical Launch KPIs, including & MSL...
- ...maintain effective collaboration with gRED, pRED/LMR, PTD, GPD, GPS, and PT (Commercial Manufacturing, CGT, Quality, Supply Chain. Regulatory) to ensure seamless product development, process and knowledge transfer to clinical and commercial manufacturing operations and...Flexible Arbeitszeit
- ...to activities in fresh markets, documenting them comprehensively Monitor and analyse forthcoming and recently enacted tax laws, regulatory positions, legal rulings, and court cases impacting the company's direct tax position. Propose strategic action steps as required...
- ...technologies (pharmaceutical / in-silico) in conjunction with Health Authorities expectations. Engage in industry consortia to shape regulatory environment and influence key opinion leaders. Liaise with key stakeholders, including Biomedical Research, Global Program...
- ...and coordinating activities across a matrix team. A SME in DP manufacturing with extensive knowledge in development, quality, and regulatory requirements for manufacturing Manages all aspects of DP Manufacturing from authoring and revision of manufacturing documents...Soforteinstellung
- ...functional communications to align with global strategy and leads the development of clinical sections of trial and program level regulatory documents • Acts as the medical expert, engages interactions with external stakeholders (e.g., regulatory authorities, key...
- ...alignment and effective collaboration with key internal partners including gRED, pRED/LMR, CPMF, Commercial DP and DS sites, Quality, Regulatory, Supply Chain, PTD Biologics Technical Development departments, Technical Development Teams, and the rest of Technical...Flexible Arbeitszeit
- ...Ensure and implement statistically sound approaches for the design, analysis, reporting, and interpretation of exploratory and regulatory non-clinical studies. Automation Development: Develop automated solutions Education: Ph.D. or Masters in Statistics, Biostatistics...Remote job
- ...status Closely interface with project team leaders as well as safety, clinical pharmacology, clinical operations, biostatistics, regulatory, research and biomarker groups and other members of project teams Lead and/or support internal stakeholder management and...Flexible Arbeitszeit
- ...Opportunity: Develop and implement a comprehensive internal control framework over sustainability reporting, ensuring alignment with regulatory requirements, including CSRD. Collaborate closely with sustainability, finance, compliance and legal teams in the process...Flexible Arbeitszeit
- ...and coordinating activities across a matrix team. A SME in DP manufacturing with extensive knowledge in development, quality, and regulatory requirements for manufacturing Manages all aspects of DP Manufacturing from authoring and revision of manufacturing documents...TemporärSoforteinstellung
- ...consent forms. Determine appropriate safety monitoring and risk management strategies. Ensure compliance with all applicable regulatory and ethical guidelines. Contribute to the preparation and submission of regulatory documents. Analyze and interpret...
- ...Oversight of any compliance investigations in the BAs organizations. Establishing and maintaining good relationships with regulatory/industry bodies, raising the standards for ethical business, promoting regulatory convergence, and increasing digital health readiness...Flexible Arbeitszeit
- ...robust understanding of how AI, data engineering, and ML can be applied in real-world scenarios to improve operational efficiency and regulatory compliance. Details Start Date: Flexible, starting from November 2024 or upon availability Duration: 8 months, with...Flexible Arbeitszeit