- Tris Pharma (Monmouth Junction, NJ)
- …Complaints (PQC) documentation, compliance efforts, quality operations, etc. Responsibilities:Assures compliance with all SOPs, cGMP, FDA , as well as all ... in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems… more
- Merck & Co. (Upper Gwynedd, PA)
- …and Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible for the execution of operational quality activities ... such as the United States of America Food and Drug Administration ( FDA ), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency,… more
- Lundbeck (Boston, MA)
- …lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand ... patients including the full range of treatment options available. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and regulatory… more
- Lundbeck (San Diego, CA)
- …transform lives. Join us on our journey of growth!As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and… more
- BioAgilytix (Durham, NC)
- …LIMS).Experience with ITIL-based processes and frameworks.Experience in regulated environments (eg, FDA , GMP, GDPR compliance , GAMP, etc.) and familiarity with ... As the IT Project Manager at BioAgilytix, you will lead and manage cross-functional IT projects spanning business systems, laboratory systems (ELN, LIMS), and IT… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... Global Clinical Operations, regulatory affairs, medical affairs, legal, communications, compliance , etc. Externally, this role may regularly interact with patients,… more
- Lundbeck (Detroit, MI)
- …and transform lives. Join us on our journey of growth!As a Neuroscience Account Manager , this is an incredible opportunity to join the growing promotion of our CNS ... to other payer channels including Medicaid and Commercial. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing). ... meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global Quality departments… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …documents (eg, clinical overviews, formulary dossiers, online evidence repository). Ensure compliance with FDA requirements as they affect medical ... health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …recommend, own, and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences ensuring consistent quality standards ... are maintained.Key Responsibilities Support area Manager and work closely with investigators to ensure investigations are completed on time and as per… more
- Eisai, Inc (Providence, RI)
- …speaker programs for meaningfulness, effectiveness, educational in nature, and compliance with company policies. Key responsibilities include:KOL Engagement Engage ... the patient journeyIdentify and ensure training (product, disease state and compliance training) for promotional speakers and related aspects of speaker… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This ... Essential Functions Reviews all manufacturing and support records to certify compliance with specifications and procedures Releases product based on Quality… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management activities. Takes ownership to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Division of the Company. [Specific assignments to be determined by direct manager of the role.]- Creates, implements, and presents training programs and materials ... school experience required- 4 or More Years experience in regulatory, compliance , and legal matters relating to investigational products, product promotion,… more
- Texas State University (San Marcos, TX)
- … Back-Up Program Coordinator and will assist the Program Manager ( FDA State Program Coordinator) in ensuring compliance with contractual obligations, FDA ... The Program Coordinator will work closely with the Program Manager ( FDA State Program Coordinator) to...provide oversight to the Food and Drug Administration ( FDA ) State Tobacco Compliance Check Inspection… more
- Olympus Corporation of the Americas (Westborough, MA)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || ... cross-functional team to investigate and develop responses to Quality/Regulatory compliance communications. Authors, leads and manages all Quality/Regulatory … more
- HCA Healthcare (Nashville, TN)
- …Do you want to join an organization that invests in you as a(an) Medication Compliance Manager ? At HCA Healthcare, you come first. HCA Healthcare has committed ... a difference. We are looking for a dedicated Medication Compliance Manager like you to be a...related to controlled substance management and diversion (eg DEA, FDA , CMS, Board of Pharmacy, The Joint Commission, and… more
- Lundbeck (Deerfield, IL)
- Manager Commercial Operations Compliance - Remote Opportunity Requisition ID: 5811 Location: Deerfield, IL, US Do you want to join a team where the mission is ... candidates anywhere in the greater United States** **SUMMARY:** The Manager , Commercial Operations Compliance will have primary...leadership and compliance summaries. + Lead sample compliance meetings and manage vendor reporting to FDA… more
- CSL Behring (King Of Prussia, PA)
- **The Opportunity:** Reporting to the Enterprise Sr. Manager , Americas Trade Compliance , as the **Enterprise Manager , Americas Trade Compliance ** , you ... for the execution and maintenance of CSL's world-class import-export compliance program in the Americas Region. Your focus will...spend and savings metric monthly reports. + Responsible for FDA US import coding and USDA coding and permitting… more
- Nestle (Bridgewater, NJ)
- …of health and nutrition for patients and consumers. Reporting to the Director of Compliance , the Manager , Pharma Compliance is responsible for supporting the ... and communications plan to address new business initiatives and ensure compliance with FDA and federal healthcare program requirements, and all other applicable… more
