- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for producing ... scientifically accurate, high- quality clinical ...strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …global regulatory strategy for assigned programs to ensure timely and high- quality regulatory deliverables to the GPTs Lead health authority interactions, ... merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of...functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues… more
- The George Washington University (Washington, DC)
- I. JOB OVERVIEW Job Description Summary: The Director , Regulatory Oversight position reports to the Associate Provost Research Integrity and Compliance (AP-RIC) ... administrative oversight of the research radiation and laser safety programs. The Director , Regulatory Oversight works closely with Office of Research Integrity… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director /Senior Director , Clinical Quality Assurance. This is a hybrid ... position. Job Title commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance provides… more
- ITS Con Global (Fort Worth, TX)
- OverviewThe Director , Safety and Regulatory Compliance is responsible for the successful development, implementation, maintenance, communication and training of ... and other state, local or industry specific regulations. The Director , Safety and Regulatory Compliance will manage...strategic level to ensure the organization meets the safety, quality , and regulatory compliance. Proactively plan and… more
- Signature HealthCARE (Owensboro, KY)
- …cognitive care, and telemedicineA growing number of our centers are earning quality assurance accreditation and pioneering person - directed careMany of our skilled ... HealthCARE! How you Will make a difference Ensure that a company-wide regulatory compliance program is ongoing in accordance with company policies, standards of… more
- Signature HealthCARE (Nashville, TN)
- …cognitive care, and telemedicine. A growing number of our centers are earning quality assurance accreditation and pioneering person - directed care. Many of our ... you Will make a difference Ensure that a company-wide regulatory compliance program is ongoing in accordance with company...meet state/federal regulations to promote excellence in care and quality of life for each resident. Provide oversight and… more
- Merck & Co. (Rahway, NJ)
- …of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC… more
- Merck & Co. (Rahway, NJ)
- …CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful ... and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- UT Health Tyler (Tyler, TX)
- …Health East Texas is advancing healthcare, together. POSITION SUMMARY The position of Quality and Patient Safety Director at UTHET is accountable for assisting ... or statistical tools. Evaluates and makes recommendations for system improvements using quality data, event and regulatory compliance reports. Provides project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' ... projects are delivered on time, within budget, and meet high- quality standards. Ensure effective communication and issue resolution.Communication and Collaboration:… more
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