- Merck & Co. (Upper Gwynedd, PA)
- …analysis, regulatory reporting, and publication. -- Responsibilities: Specifically, the Senior Director may be responsible for: -Analyzing and summarizing ... create breakthrough science that radically changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in the… 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)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the regulatory ... identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in alignment with… 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 ... patient care advances. The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset management issues and is part of… more
- Eisai, Inc (Nutley, NJ)
- …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 ... journals on clinical quality topics.Build and manage overall relationships with regulatory bodies to address emerging needs and issues.Manage and retain talent… more
- Tris Pharma (Monmouth Junction, NJ)
- …Director / Director , Procurement. Title and salary commensurate with experience. The Director / Senior Director , Procurement is responsible for multiple ... and assurance of compliance with GxP and other company and regulatory agency procurement policies and procedures throughout the organization. Ensures compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx submission ... for the drug trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and understands the competitive landscape.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the development and implementation of integrated ... the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical development plans, clinical protocols, and in the submission of certain regulatory documents, as well as supporting commercial in developing a strategy ... development plans, clinical protocols, and in the submission of certain regulatory documents. Support commercial in developing a strategy including patient selection… 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...with GCP, GPV, GPEP, Data Protection, and other local regulatory requirements throughout the planning and execution of Interventional,… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for ... The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be... Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (ED) for US Medical Affairs (USMA) understands Our Company's enterprise level strategies and leads cross-functionally with the ... for the US, including tactical execution by the field Regional Medical Scientific Director (RMSD) teams and is accountable for ensuring field teams execute on… 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 ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Merck & Co. (North Wales, PA)
- …of the CIPM Staff Manager & Portfolio Lead, the core responsibility of this senior Project Manager (PM) role will be to manage CMC programs, due diligence and ... "oversight" is expected at this level. In addition, the Director may be expected to take on one of...levels inside and outside of the organization, specifically with senior management.Sufficient skill levels and technical understanding of CMC… 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 ... to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new...to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle… 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 ... in accordance with GAAP.Ensure timely and accurate financial reporting to senior management and external stakeholders, including quarterly and annual filings (eg,… more
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... including deviation support, root cause analysis, customer complaint management, hosting customer/ regulatory audits and Certificate of Quality generation at an ISO… 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
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