- Merck & Co. (San Diego, CA)
- …Skills:Biological Sciences, Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance , Leadership, Motivation ... with global regulatory authorities to ensure successful registration and compliance . Global Immunology submission experience in IBD strongly preferred. Primary… more
- Tris Pharma (Monmouth Junction, NJ)
- …anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US We also ... supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory agency… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the appropriate tool (eg, disproportionality assessments).This individual will ensure compliance with applicable domestic and international regulations and ... across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of continuous improvement in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audits, and high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the ... Management:Lead the end-to-end quality execution across Medical Affairs programs, ensuring compliance with GCP, GPV, GPEP, Data Protection, and other local… more
- Genmab (NJ)
- …organize, prioritize, and work effectively in a constantly changing environmentStrong compliance knowledge and adherence to corporate compliance policiesCurrent ... of FDA, OIG, ICH, GCP, PhRMA Code, HIPAA and other compliance regulations and guidelines relevant to industry interactions with healthcare professionalsDemonstrated… more
- Insmed Incorporated (San Diego, CA)
- …Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical ... all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines.ResponsibilitiesResponsibilities (Essential Role… more
- Tris Pharma (Houston, TX)
- …medicines addressing unmet patient needs. We have over 150 US and International patents - including applications - and several marketed branded and generic ... We have licensed our products in the US and international markets and have a robust pipeline of innovative...to all Standard Operating Procedures (SOPs), policies, processes and compliance guidelines and ensures knowledge of legal and regulatory… more
- Merck & Co. (Rahway, NJ)
- …result in outcomes that demonstrate the Company's dedication to regulatory compliance .Ensures that a cross-functional team (eg Quality & Continuous Improvement (QCI) ... provide real-time, proactive advice and guidance.Escalates potentially significant inspection findings/ compliance risks/impact to Company Senior Management.Develops the inspection management… more
- Eisai, Inc (Raleigh, NC)
- …scheduling meetings, coordinating logistics, and arranging domestic and international travel.Prepare and submit expense reports, reconcile international ... purchase orders, and manage contracts and master service agreements in compliance with global policies.Support strategic administrative initiatives and contribute to… more
- City of Spring Hill Kansas (Spring Hill, KS)
- Do you excel in leading and providing guidance as it relates to codes and compliance ? Do you have expertise in inspecting and compliance ? If yes, then look no ... organizational, public relations, and communication skills. Oversee building code compliance , managing inspections and ensuring safety standards in construction… more
- Merck & Co. (Rahway, NJ)
- …Substance.-Lead tiered meeting structure coordinating activities locally and with international (US, Ireland, Switzerland) groups for implementation of new processes ... with key stakeholders.Training skills: Ability to train employees in technical, compliance , safety, and environmental procedures; ability to write SOPs and technical… more
- Merck & Co. (North Wales, PA)
- …packaging process and equipment issues, optimizing processes, and ensuring compliance . Effective collaboration with site-based and above-site based functional teams ... advanced skills in creating and improving business, technical, and compliance processes, and leading high-impact cross-functional teams.Responsible to lead or… more
- Repligen (Waltham, MA)
- …has a high degree of exposure to the complexities of a multi-site international public company. Seeking a candidate with in-depth knowledge of generally accepted ... approach with teams across the organization. Internal Controls & Compliance :Design, implement, and maintain effective internal controls over financial reporting… more
- Merck & Co. (Rahway, NJ)
- …and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise wide ... shooting and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …authorship agreements, financial disclosures and author approvals- Ensure documentation of compliance with authorship and publication guidelines as stipulated by the ... International Committee of Medical Journal Editors (ICMJE) and Good...to achieve goals preferred- Experience with clinical trials and international work experience preferred TravelAbility to travel up to… more
- Merck & Co. (Rahway, NJ)
- …in local regulatory frameworks, ethical standards, and pharmaceutical compliance requirements.Proven capability to cultivate and sustain strategic partnerships ... and publication experience in the TA, including knowledge of national/ international treatment guidelines, quality measures, and collaboration networks, supporting… more
- Merck & Co. (Rahway, NJ)
- …analysis, regulatory reporting, publication, and presentation at national and international meeting.- They will provide internal scientific leadership for ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …collaborate and lead resolution of Regulatory, Reputational (ie Public Relations), Compliance and other Asset issues management Substantive contributions to labeling ... Experience and Skills: 5+ years pharmaceutical (or related) industry experience in international role with proven track record of contribution to medical, clinical… more
- Merck & Co. (Rahway, NJ)
- …consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents ... Process Management (BPM), Client-Focused, Client Relationship Building, Collaborative Communications, Compliance Packaging, Confidentiality, Effective Listening, Engineering Standards, Leadership, Leading… more
- Merck & Co. (Rahway, NJ)
- …will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices (cGMPs), and participating ... the laboratories at the Rahway, New Jersey site with occasional domestic and international travel, as necessary. This is primarily a laboratory-based roll and onsite… more
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