- Merck & Co. (Rahway, NJ)
- …approvals and systems are in place to maintain the scientific, technical and regulatory quality of all CMC submissions, correspondence, and interactions with ... our company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high- quality submissions for products that may… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the CMC post ... development program and life cycle management, and ensure they meet current regulatory standards, are of high quality , consistent, and complete.Establish product… more
- National Veterinary Associates (Yuma, AZ)
- Ironwood Veterinary Clinic, located in Yuma, AZ, is looking for aMedical Director / Managing Veterinarian to join our practiceIronwood Veterinary Clinic in Yuma, ... and community, you would then smoothly transition to the JV Partner/Medical Director .The responsibilities as the Medical Director / Managing Veterinarian include… more
- Insmed Incorporated (San Diego, CA)
- …each other, and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on ... plansIndependently lead the central messaging, preparation, and submission of high quality , regulatory complaint regulatory dossiersDirect hands-on… more
- National Veterinary Associates (Vero Beach South, FL)
- Vero Beach Veterinary Hospital is seeking a Medical Director to join our AAHA-accredited team! We can offer up to $50K in bonuses comprised of sign-on, retention, ... needs and those of the hospital. No on-call or after-hours. Quality of Life - It offers scenic shores, plus...tennis, and so much more.The Opportunity: As the Medical Director at Vero Beach Veterinary Hospital, you will provide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary: The GCO Senior Director of Study Optimization has accountability for the oversight, management, and ... implement a continuous process improvement framework for clinical operations ensuring quality and optimal delivery.Solicit GCO needs, ensure cumulative tracking in… 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
- Eisai, Inc (Nutley, NJ)
- …industry-wide QA community, present, publish at conferences, journals on clinical quality topics.Build and manage overall relationships with regulatory bodies ... significant clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance).Substantial experience in Clinical Quality /CQA… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Quality Control will be responsible for leading and overseeing all ... execution of release, stability, and in-process testing in accordance with cGMP, regulatory requirements, and company quality standards. The successful candidate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Management to ensure safety information is processed according to corporate timelines, quality and regulatory requirements Leads the safety follow-up process ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Insmed Incorporated (NJ)
- …internal teams and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, ... of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for...biologics, drug products, or combination products.Deep knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Parts… more
- Merck & Co. (North Wales, PA)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... of process questions and issues related to submission content management, quality and standards complianceEngage across functional areas to identify opportunities… 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 ... fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director 's Medical Affairs … more
- Insmed Incorporated (San Diego, CA)
- …for the future of science, we're in. Are you?About the Role:Reporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical ... Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy… more
- Merck & Co. (Rahway, NJ)
- …and coach to the HF team and key stakeholders across R&D, clinical, regulatory , marketing, manufacturing, and quality functions.Educate and build awareness of HF ... Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary...represent the company externally to influence industry standards and regulatory practices.-Primary Scientific & Leadership Requirements - HF Influence… more
- Merck & Co. (Montgomery County, PA)
- …the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), Consumer (HCC), ... collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will… more
- Eisai, Inc (Durham, NC)
- …and make a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance ... activities. Eisai Salary Transparency Language:The base salary range for the Director , Clinical Quality Assurance is from :195,000-256,000Under current… more
- Merck & Co. (Millsboro, DE)
- …leaders and frontline teams, and who works effectively across functional partners. Quality - and compliance-focused with practical experience supporting regulatory ... Integrated Process Team that directly influences site performance, product quality and cost-of-goods for life-changing animal vaccines. Your leadership will… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Engineering, Packaging Commercialization will lead packaging development for new products including parenteral products ... developing and commercializing new products on cross-functional teams. - - The Associate Director will be accountable for the d efinition and execution of overall… more
- Merck & Co. (Rahway, NJ)
- …Knowledge of business functions including Technology, Manufacturing Operations, Finance, Regulatory , Quality , Compliance, Supply Chain and Commercial. ... As a result, VCM Product Leaders have direct impact on cost, quality , customer service, and compliance which ultimately affects access, continuity of supply,… more
