- 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 ... lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high- quality submissions...across divisions/ business units and in the external business and regulatory environment to identify potential… more
- Merck & Co. (North Wales, PA)
- …operations of a modern Veeva RIM Vault A MUST!Knowledge of the regulatory submission processes, systems, and business requirementsExperience working closely with ... ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end... Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on… more
- NVA (Yuma, AZ)
- Ironwood Veterinary Clinic, located in Yuma, AZ, is looking for aMedical Director / Managing Veterinarian to join our practiceIronwood Veterinary Clinic in Yuma, ... you would then smoothly transition to the JV Partner/Medical Director .The responsibilities as the Medical Director /... / Managing Veterinarian include continuing to grow the business , provide exceptional medical care to our patients, leading… 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 ... the development of assigned programs in alignment with Insmed's business needs.ResponsibilitiesResponsibilities:Independently serving as the regulatory representative… more
- CoxHealth (Lake Spring, MO)
- …efficient care. The incumbent provides oversight and management of operational, regulatory , and business processes across the Springfield perioperative ... self-development to achieve excellence in operations, patient safety and quality . Excellent communication skills, leadership ability, time management, finance, and… 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
- Merck & Co. (Rahway, NJ)
- …Description Position Description: As a member of the Company's Research Laboratories Quality Assurance community, provide for and lead Quality Assurance ... oversight for computer system validation matters within the Global Development Quality organization and for the Company's Research & Development division.For our… 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
- 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
- Eisai, Inc (Nutley, NJ)
- …and drive execution as a part of that plan.Champion CQA's mission of ' Quality as enabler of business '; lead global initiatives for continuous improvement.Trend ... industry-wide QA community, present, publish at conferences, journals on clinical quality topics.Build and manage overall relationships with regulatory bodies… 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 ... mindset with Medical Affairs.Support the Sr. Director 's Medical Affairs Quality strategy by partnering with members and business stakeholders for both… 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. (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
- Merck & Co. (Rahway, NJ)
- …Estimation and Planning, Maintenance Supervision, Management Process, Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing Systems, Regulatory ... strategic and tactical technical direction through cross-functional partnerships with key business units and customers. Your leadership will be instrumental in… more
- Merck & Co. (Rahway, NJ)
- …of business functions including Technology, Manufacturing Operations, Finance, Regulatory , Quality , Compliance, Supply Chain and Commercial. Understanding of ... As a result, VCM Product Leaders have direct impact on cost, quality , customer service, and compliance which ultimately affects access, continuity of supply,… 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
- Insmed Incorporated (San Diego, CA)
- …solutions comply with GCP, 21 CFR Part 11, and CDISC ODM StandardsData Quality & Compliance:Ensure EDC systems comply with regulatory requirements (eg, FDA, ... Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , EDC Programming will lead and oversee EDC programming, and… more
- Lundbeck (North Hyde, SD)
- …approval, lifecycle management and alignment with industry standards while supporting the business strategic objectives. Reporting to the Medical Director , we ... with regulatory bodies on product information, storage, shipment, and quality standards. Respond to investigations and queries related to product integrity,… more
- Merck & Co. (Rahway, NJ)
- …packaging & device development and technology teams, supply chain, operations, quality , analytical, regulatory , and project leaders. The successful candidate ... maintain strong relationships with internal stakeholders, including packaging commercialization, quality , analytical, regulatory , manufacturing, Device Development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ensure ... ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust communication plan including status and timing… more
