- Merck & Co. (Upper Gwynedd, PA)
- …analysis, regulatory reporting, and publication. -- Responsibilities: Specifically, the Senior Director may be responsible for: -Analyzing and summarizing ... radically changes the way we approach serious diseases. --The Senior Director will report to an Associate...of Action and Milestones (POA&M), Regulatory Affairs Compliance , Regulatory Compliance {+ 5… more
- Merck & Co. (Rahway, NJ)
- …placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director may be responsible for: Providing scientific and ... medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of clinical development,… more
- Merck & Co. (Boston, MA)
- …execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre-clinical and ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff ... and ensure ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust communication plan including… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Senior Director of Medical Affairs (GDMA) for Melanoma coordinates the development of the Global Scientific and Medical Affairs Plans ... Asset Regulatory Management Successfully collaborate and lead resolution of Regulatory , Reputational (ie Public Relations), Compliance and other Asset issues… more
- Eisai, Inc (Nutley, NJ)
- …significant clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in Clinical Quality /CQA ... per week#LI-CCEisai Salary Transparency Language:The base salary range for the Senior Director , Clinical Quality Assurance is from :236,900-310,900Under current… more
- Tris Pharma (Monmouth Junction, NJ)
- …Director / Director , Procurement. Title and salary commensurate with experience. The Director / Senior Director , Procurement is responsible for multiple ... negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with… more
- Merck & Co. (Rahway, NJ)
- …identify growth opportunities and drive innovation.In-depth expertise in local regulatory frameworks, ethical standards, and pharmaceutical compliance ... Job DescriptionThe Executive Director (ED) for US Medical Affairs (USMA) understands...Medical strategy and execution.Primary Responsibilities:Leadership and ManagementServes as a senior leader in the USMA organization, sets the strategic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring, development, and ... in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations...and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of… more
- Repligen (Waltham, MA)
- …global public company is looking for a strong, experienced, and technically sound Senior Director , Assistant Controller, who will own the Company's accounting ... reporting (ICFR) in compliance with Sarbanes-Oxley (SOX) requirements.Ensure compliance with accounting standards and regulatory requirements, including SEC… more
- Merck & Co. (North Wales, PA)
- …Budgeting, Project Management, Project Planning, Project Scheduling, Project Strategy, Regulatory Compliance , Results-Oriented, Risk Management, Software Project ... Manager & Portfolio Lead, the core responsibility of this senior Project Manager (PM) role will be to manage..."oversight" is expected at this level. In addition, the Director may be expected to take on one of… more
- Merck & Co. (Rahway, NJ)
- …integrating state-of-the-art technology and applying rigorous scientific and ethical standards.The Senior Director ( Senior Principal Scientist) has primary ... development (pre-clinical to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle of clinical development,… more
- Repligen (Waltham, MA)
- …, Quality - Quality Network Leader, Chromatography & Proteins.ResponsibilitiesThe Director , Quality will be responsible for:Maintaining site compliance ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham,...deviation support, root cause analysis, customer complaint management, hosting customer/ regulatory audits and Certificate of Quality generation at an… more
- Merck & Co. (Rahway, NJ)
- …execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director may be responsible for:Evaluating pre-clinical and ... Job Description-The Senior Director ( Senior Principal...Disease Treatment, Pulmonary Disorders, Pulmonology, Regulatory Affairs Compliance , Regulatory Compliance , Scientific Consulting… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising,… more
- Eisai, Inc (Nutley, NJ)
- …and provide input into CME budget and website portal as needed. Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical ... If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and execution… more
- Merck & Co. (Millsboro, DE)
- …for product release, aseptic operations, formulation and fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and ... teams, and who works effectively across functional partners.Quality- and compliance -focused with practical experience supporting regulatory inspections,… more
- Merck & Co. (Rahway, NJ)
- …monitoring, analysis, regulatory reporting, and publication. Specifically, the Senior Director may be responsible for:Evaluating pre-clinical and ... with talented and dedicated colleagues while developing and expanding your career. Senior Director ( Senior Principal Scientist) has primary responsibility… more
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