- Eisai, Inc (Nutley, NJ)
- … pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in Clinical Quality /CQA conducting a ... management system. This role is responsible for Good Clinical Practice (GCP) and for assuring the compliance...Salary Transparency Language:The base salary range for the Senior Director , Clinical Quality Assurance is… more
- Symphony Talent, LLC (Miramar, FL)
- …Memorial, we are dedicated to improving the health, well-being and, most of all, quality of life for the people entrusted to our care. An unwavering commitment to ... implements departmental goals, plans, and standards consistent with the clinical , administrative, legal, and ethical requirements/objectives of the organization.Directs… more
- Merck & Co. (Lower Gwynedd, PA)
- …our company's Springhouse Innovation Park facility in Lower Gwynedd Township, PA.-The successful Compliance Director candidate will lead a team that focuses on ... Job DescriptionThe PDMB Regulated Bioanalytics Department is seeking a Director to lead the Compliance team within the Late Development (AdVAnce) Vaccines… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …target product profile (TPP) development, due diligence projects, and clinical -regulatory compliance . ResponsibilitiesEssential Duties and Responsibilities ... Clinical Development: Design and execute clinical trials for respiratory products, ensuring compliance with regulatory requirements.Collaborate with… more
- Eisai, Inc (Nutley, NJ)
- …environment and make a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical ... Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard...Eisai Salary Transparency Language:The base salary range for the Director , Clinical Quality Assurance is… more
- Insmed Incorporated (San Diego, CA)
- …Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director ... Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs,...regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical … 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 ... the clinical operational and overall delivery and tactical execution of the clinical studies. The senior director will ensure a strong focus on competencies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director 's Medical Affairs ... across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director… more
- Merck & Co. (North Wales, PA)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle of clinical...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Insmed Incorporated (San Diego, CA)
- …be responsible for the development and implementation of EDC systems to support clinical trials, ensuring data quality , compliance , and efficiency throughout ... solutions comply with GCP, 21 CFR Part 11, and CDISC ODM StandardsData Quality & Compliance :Ensure EDC systems comply with regulatory requirements (eg, FDA,… more
- Merck & Co. (Rahway, NJ)
- …and execute design verification strategies that successfully supports the clinical instruction(s) and commercial market approval(s) of combination products.Principal ... strategies for assigned drug-device combination product program(s) for successful clinical introduction(s) and commercial market(s) approval(s).Define design input(s)/ output(s)… more
- Merck & Co. (Rahway, NJ)
- …direction and value creation for our company's Global Animal Health enterprise.The Director , Enterprise Strategy will be considered a leader in the global Strategy ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …leader to drive pipeline impact and lead a talented group of pharmacometricians.This director will be part of a leadership team responsible for applying traditional ... continue to innovate our pharmacometrics capabilities on a continuous basis. The Director will be accountable for directing a team of pharmacometricians with diverse… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and tracking as well as instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool (eg, disproportionality ... and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole Summary:The Executive Director , Value & Implementation (V&I) Outcomes Research position resides in the V&I organization, which includes Global ... cross-functional teams is a critical part of this role. The Executive Director has scientific and budgetary oversight for all outcomes research activities conducted… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.- Ensures ... to database release, data review and cleaning, database lock), to ensure data quality /integrity and regulatory compliance - Ensures that Data Management Plans are… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Executive Director of Metabolism & Obesity will be responsible for overseeing and facilitating the research in metabolic diseases & obesity and ... data science, while focusing on uncovering novel biology that delivers high- quality drug discovery pipeline.-We are a research-driven biopharmaceutical company. -Our… more
- Merck & Co. (Rahway, NJ)
- …a matrix team including product development teams and internal partner groups ( quality , analytical,- procurement, and global clinical supply). Projects may ... Job DescriptionOur company's Pharmaceutical Sciences and Clinical Supply (PSCS) organization translates molecules to medicines, working from the discovery interface… more
- Insmed Incorporated (San Diego, CA)
- …Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the regulatory leader on ... risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in alignment with Insmed's… more
