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- Lancaster, SC
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The QA Supervisor reports to the Assistant QA Manager. This person supervises Quality Assurance Generalists and label Issuance but may include other personnel in Quality Assurance Department. The QA Supervisor is responsible for all of the day to day operations, techniques, documentation, and activities associated with those departments that are used to fulfill the Quality Assurance requirements of the product and/or service. Floor presence is required to be successful in this roleRoles and....


We are looking for an Associate Director of Regulatory Affairs to lead and drive the regulatory affairs activities and initiatives in support of strategy, development, and submission. This position is a key member of project teams and is responsible for implementation of regulatory strategies across multiple programs. This position is expected to bring a combined knowledge of scientific, regulatory, and business issues to all relevant stakeholders to ensure products meet regulatory standards....


We are looking for an Associate Director of Regulatory Affairs to lead and drive the regulatory affairs activities and initiatives in support of strategy, development, and submission. This position is a key member of project teams and is responsible for implementation of regulatory strategies across multiple programs. This position is expected to bring a combined knowledge of scientific, regulatory, and business issues to all relevant stakeholders to ensure products meet regulatory standards....


Education/ExperienceBS in life sciences or related field At least 2 years experience in clinical researchKnowledge of FDA regulations Prior Study Start-Up experience preferredAdvanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook Experience with Adobe Acrobat Professional and Microsoft Access a plusPresentation Delivery ResponsibilitiesExecute study start-up for assigned protocols within company timelines by identifying clinical team needs, Oversee Site....

- Cambridge, MA

Regulatory Affairs Advisor - Medical Device Cambridge, MA Overview: Our client is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean markets. They are committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based service and support for all of the products it distributes in the United States. They are currently seeking a Regulatory Affairs Advisor for....


The QA Supervisor reports to the Assistant QA Manager. This person supervises Quality Assurance Generalists and label Issuance but may include other personnel in Quality Assurance Department. The QA Supervisor is responsible for all of the day to day operations, techniques, documentation, and activities associated with those departments that are used to fulfill the Quality Assurance requirements of the product and/or service. Floor presence is required to be successful in this roleRoles and....

- Cranford, NJ

Cranford, NJ, United States Full TimePOSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives. This position is based in Client's Cranford, New Jersey office. Essential Job Functions/ResponsibilitiesParticipates in the preparation and/or review of draft protocol and informed consent documentsPossesses detailed knowledge of the study protocol and its associated activities and timelinesParticipates in conference calls,....


POSITION OBJECTIVE: The Clinical Research Physician will be dedicated to providing a leadership role on a matrix team dedicated to stage appropriate clinical development of multiple innovative compounds. He or she will lead the development of clinical strategies for compounds and drive their successful implementation. This position is based in Client's New Jersey office. It is an office based position. Remote candidates will not be considered for this role. Essential Job....

- Cranford, NJ

Senior Clinical Research Associate POSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives. . Essential Job Functions/ResponsibilitiesParticipates in the preparation and/or review of draft protocol and informed consent documentsPossesses detailed knowledge of the study protocol and its associated activities and timelinesParticipates in conference calls, prepares agenda and summariesCoordinates with project team and other study....

- Cranford, NJ

As a Clinical Study Monitor, you will work within a clinical team setting to ensure study compliance with protocol, FDA and ICH guidelines. Essential Job Functions/Responsibilities · Ensure the Sponsor, Investigator, and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures. · Adhere to monitoring plan protocols; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring....


The Manager, Medical Information will assist in the operational oversight of medical information within the Medical Affairs function under the guidance of the Lead of Medical Information. The manager will be responsible for providing and supporting the provision of accurate, scientifically balanced and timely responses to inquiries received from health care professionals, consumers and other customers. The manager will monitor the scientific literature and communicate new data to relevant....


This key leadership role in the Regulatory Affairs organization and will report directly to the Senior Vice President, Regulatory Affairs & Medical Writing. The incumbent in this role will lead the regulatory strategy group for the defined therapeutic area(CNS) to this position will provide expert leadership and managerial oversight for pre-approval and post-approval projects to ensure delivery of high quality regulatory strategy and submissions. Further, this position will guide....


Join a leading global organization in their Product/ Metabolism discovery and safety studies team. Requires Scientific expertise in biological or chemical sciences of environmental, plant or mammalian studies of agrichemical molecules. ---Participate as Lead Scientist with expertise in Data Chemistry, analysis testing utilizing Chromatography and other relative methodology. ---Support the use of data sets to optimize study design and overall understanding of the compounds behavior ---Manage....


RETAINED RESEARCH Title: Director of Regulatory Affairs Direct Reports 2 Mgrs Indirect Reports: 8 -10 Responsible for coordinating quality regulatory submissions to the United States Department of Agriculture’s (USDA), specifically The Center of Veterinary Biologics (CVB), and following USDA licensure, coordinating dossier submissions to regulatory authorities in countries, including affiliates and distributors. Manage US Regulatory Affairs Department:Manage and oversee licensure of new....


We are looking for a Corporate Trainer who will develop, maintain, and administer training programs. General Responsibilities:Work with management to develop and/or implement company training programs and workshop to employees and manager such as training profiles, On the Job Training, Train the Trainer programs, supervisory, management, work skills, and communication.Monitors the effectiveness of training on employees using individual and/or group performance results. Collects feedback on....


Global Pharmaceutical company with marketed products, new launch and strong pipeline is growing and looking for a Medical Information Senior Manager: Must be PharmD, Phd or MD Assist as company grows for building out the US Medical Information team Responsible for prompt and accurate responses to Medical Information inquiries from internal and external customers received through the MI Customer Management Center, email, fax and websites Ensures that the documentation of the inquiries and....


The Associate/Director Medical Director, Medical Affairs will provide support for an investigational treatment currently in Phase 3 clinical development for schizophrenia.In this newly created role you will support key medical strategies and tactics that align with Brand objectives, and work collaboratively with other functions (e.g., Clinical Development, Field Medical, Scientific Communications, Regulatory, Commercial and Brand Teams).RESPONSIBILITIES:Provide medical affairs expertise and....


Exclusive Nationwide Search for Senior Medical Director to Assist the Chief Medical Officer (CMO) to direct and coordinate the medical affairs functions for the business enterprise. Oversee the denials and appeals department. May manage other medical directors. Medical Leadership Provide medical leadership for all utilization management, pharmacy, case management, disease management, cost containment, and medical quality improvement activities. Perform medical review activities pertaining to....


Sr. Manager / Director, Medical Affairs Overview: Diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what....


Global Pharmaceutical company is hiring an Executive Director to head up their Renal Medical Affairs Division this Executive role will report into the Executive Vice President of Medical Affairs and spear head the high profil department must be Nephrologist with at least 3 years of medical affairs experience Renal Cardio Medical Head (Executive Director) The Renal Cardio Medical Head is a member of the Renal-Cardio Therapeutic Area (RCTA) leadership team and leads the Renal Cardio Core Medical

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