- 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)
- …the Sr. Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with… more
- Merck & Co. (Upper Gwynedd, PA)
- …Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance , Regulatory Compliance {+ 5 more}-Preferred Skills:Job Posting ... science that radically changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in the Oncology Clinical… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director ... dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the planning… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Utilize extensive experience in ... Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership...conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities: Strategic Leadership and Project ... Job DescriptionJob Summary: The Director , Combination Product Commercialization is a key leadership...of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance: Ensure that… more
- Merck & Co. (South San Francisco, CA)
- …Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology pipelines. - As ... an Associate Director , you will represent QP2 on cr o ss-...vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... pipeline impact and lead a talented group of pharmacometricians.This director will be part of a leadership team responsible...cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management processes across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- Insmed Incorporated (San Diego, CA)
- …technical expertise and system documentationEnsure data integrity, system reliability, and regulatory compliance across all phases of clinical developmentTeam ... comply with GCP, 21 CFR Part 11, and CDISC ODM StandardsData Quality & Compliance :Ensure EDC systems comply with regulatory requirements (eg, FDA, EMA, ICH-GCP)… more
