- 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. (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)
- 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
- 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
- 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
- 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
- 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)
- …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
- 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)
- … 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
- 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)
- 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
- 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
- Merck & Co. (Millsboro, DE)
- Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly influences site performance, product quality ... operations, formulation and fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT support for audits,… 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...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (Rahway, NJ)
- …to write SOPs and technical documents and present to peers and senior management.Analytical skills: Ability to analyze complex data and make recommendations for ... and/or large facility builds or renovations.A thorough understanding of regulatory /compliance expectations across all phases of product development and… 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
- 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
