- Merck & Co. (Lower Gwynedd, PA)
- …Us: The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... and other key internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing relationships with internal… more
- Merck & Co. (Durham, NC)
- …customers and patients on time, every time, across the globe. Reporting to the Director of Quality Systems and Compliance, the Associate Director - ... with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personal development. Are you ready to maximize your potential with us? The Position The Associate Director will be the lead who is responsible for ensuring that ... Reports to the Sr. Director , Patient Support Solution Quality/Safety Associate Director . Interacts with colleagues within Patient Support Programs, Patient… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in ... stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance the efficiency of… more
- Genmab (NJ)
- …be our best, and authentic is essential to fulfilling our purpose.The Role:An Associate Director , Data Management is operationally responsible for the oversight ... timely delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will provide oversight to ensure end-to-end data management… more
- Genmab (Plainsboro, NJ)
- …implemented, and utilized at a pace never seen before. Join Genmab as an Associate Director , Solution Architecture and Engineering, R&D Digital Products as part ... environments to join our IT R&D Digital Products Team. This role will be reporting to the Director of Engineering and Solution Architecture, R&D Digital… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, ECP keeps us accountable every step of the way ... business on impactful risk mitigation strategies. Relationships Reports to the Senior Director , E&C Business Partner. Coordinates with employees in the Ethics &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Tax, Compliance and Legal team members to ensure compliance with all relevant regulatory , accounting, tax and internal requirements. This person leads the timely and ... external auditors. Ensures State and federal agencies inquiries and other reporting requirements are met. Provides information to other internal departments where… more
- Merck & Co. (Rahway, NJ)
- …clinical development, including study design, placement, monitoring, analysis, regulatory reporting , and publication. -- Specifically, the Director may be ... breakthrough science that radically changes the way we approach serious diseases. --The Director will report to an Associate Vice President in the Oncology… more
- Merck & Co. (Rahway, NJ)
- …cardiometabolic, rare disease, infectious diseases, neuroscience, ophthalmology, and immunology. Reporting to the Associate Vice President, Human Health ... Job DescriptionThe Executive Director , Global Pharma Communications is responsible for leading,...the company's pipeline, including during late-stage development, distribution and regulatory milestones, in a manner that reflects the company's… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Corporate Accounting guidelines in accordance with IFRS regulations. Relationships Reports to the Associate Director of Accounting at Novo Nordisk Inc. As part ... Provide monthly status reports on closing process to the Associate Director of Accounting, the Senior ...with the current and new GAAP or International Financial Reporting Standards (IFRS). Coordinates US response and recommendation for… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... of Director in the CCFS group and working in conjunction...next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will… more
- Merck & Co. (Rahway, NJ)
- …including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting , publication, and presentation at national and ... the indication of interest.Work closely with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs, statistics,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study ... conventions. Reviews and submits DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure accuracy and consistency of… more
- Merck (Lower Gwynedd, PA)
- …Us:** The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and… more
- Takeda Pharmaceuticals (Columbus, OH)
- …and Global Regulatory Affairs (GRA) technology roadmap. + Promotes regulatory information quality, reporting , and development and monitoring of KPIs ... or gaps in data and regulatory strategy. + Responsible for supporting Regulatory components of PSMF reporting , adapting strategies based on evolving global … more
- MD Anderson Cancer Center (Houston, TX)
- …employees and the public. The position is responsible for providing regulatory oversight needed for drafting applicable study documents, including protocol and ... informed consent. Responsible for investigating proactively and capitalizing regulatory information collected throughout studies and maintaining Regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies for patients with immunologic, hematologic, and other complex diseases. The Regulatory Lead is accountable for recommending and implementing regulatory ... **How you will contribute:** + Serves as the global regulatory lead for one or more projects and and... review forum for discussion. + Ensures accurate, up-to-date reporting of program status and milestones globally through the… more
- Novo Nordisk (Lexington, MA)
- …clinical development and regulatory requirements of a clinical program. The Associate Director will provide high level strategic input into development ... plans, study designs, and regulatory submissions. Relationships The Associate Director...outside the US. Development of People Supervisory Ensure that reporting personnel have individual development plans (IDP), with annual… more
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