- 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 ... as neededCollaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program Management, and external consultants to align regulatory … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPrincipal Scientist - Mixed Modalities, Sterile Product Development The Mixed Modalities team within Sterile Product Development is responsible ... inhaled dosage forms. Provide active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across… more
- Merck & Co. (Rahway, NJ)
- …individuals with opportunities to gain critical business acumen such as product knowledge, healthcare systems, payors and customers, regulatory , business ... committed to developing future leaders through the Finance Leadership Development Program (FLDP). This 2-3 year experience provides participants with hands-on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of ... excellence and compliance and working toward building a quality mindset with...with GCP, GPV, GPEP, Data Protection, and other local regulatory requirements throughout the planning and execution of Interventional,… more
- Merck & Co. (Rahway, NJ)
- …development design controls for the assigned projects.- Prepare materials for program presentations for management review and regulatory submissions, ensuring ... approach within Device Development and with external suppliers. Understand and apply regulatory / compliance requirements relative to design controls and risk… more
- Merck & Co. (Rahway, NJ)
- …Asset Regulatory Management Successfully collaborate and lead resolution of Regulatory , Reputational (ie Public Relations), Compliance and other Asset issues ... is a valued co-strategist on the Global Franchise Team and assigned Product Development (Sub-) Teams. Contributes to Life Cycle Management decisions. In addition,… more
- Merck & Co. (Boston, MA)
- ….Stay up to date with industry trends, technology advancements, and regulatory requirements for diagnostic assays.Drive diagnostic product innovation and ... stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development,… more
- Merck & Co. (North Wales, PA)
- …span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.-Design and maintain statistical ... statistical programming point of contact and knowledge holder through the entire product lifecycle for the assigned projects. Assure deliverable quality and process … more
- Merck & Co. (Boston, MA)
- …Research, Mentorship, Parasitology, Patient Care, Professional Networking, Protocol Development, Regulatory Compliance {+ 4 more}-Preferred Skills:Job Posting ... with clinical development plans. Collaborating with Discovery, Translational Medicine and Product Development Teams, you will be the authority in defining and… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.-The incumbent is responsible for… more
- Aequor (Hicksville, OH)
- …etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and ... AssistantJob PurposeAssist in the compounding and mixing of Pharmaceutical bulk product . Perform other required departmental duties as required, ie cleaning,… more
- Merck & Co. (Rahway, NJ)
- …upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial ... development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising,… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Eisai, Inc (Nutley, NJ)
- …practices that can help simplify the patient journeyIdentify and ensure training ( product , disease state and compliance training) for promotional speakers and ... issuesOffer feedback on nominating new speakers when applicableCoordinate / facilitate new product and annual compliance trainingWork with Marketing Team for… more
- Merck & Co. (North Wales, PA)
- …Budgeting, Project Management, Project Planning, Project Scheduling, Project Strategy, Regulatory Compliance , Results-Oriented, Risk Management, Software Project ... diligence and business development activities independently, regardless of complexity, phase or program type, and is based on direct experience and the ability to… more
- Merck & Co. (Rahway, NJ)
- …and stability assays for testing of clinical trial material and in support of product and process development - A strong team player with excellent oral and written ... of assays. Plan assay optimization and documentation to meet program deadlines. - Authoring and reviewing internal technical reports,...- Authoring and reviewing internal technical reports, sections of regulatory filings ( eg, IND , BLA ) and… more
- Applied Materials (Santa Clara, CA)
- …we are seeking a highly skilled and experienced PMO Professional to support our Product Regulatory Compliance program . This critical role ensures ... in Austin, TX. **Key Responsibilities** . Support and oversee the overall Product Regulatory Compliance program , ensuring alignment with organizational… more
- Applied Materials (Santa Clara, CA)
- …operations, we are seeking a highly skilled and experienced Senior PMO to support our Product Regulatory Compliance program . This critical role ensures ... office in Austin, TX. **Key Responsibilities** . Support the overall Product Regulatory Compliance program , ensuring alignment with organizational… more
- Citigroup (Irving, TX)
- … Risk Policies and relevant procedures and preparation, editing, and maintenance of Compliance program related materials. + Interacting and working with other ... protects the franchise. In addition, engages with the ICRM product and function coverage teams, in order to partner...compliance related issues. + Reviewing materials to ensure compliance with various regulatory and legal requirements… more
- Chemours (Wilmington, DE)
- …and more modern living depend on Chemours chemistry. Chemours is seeking an **APM Product ** **Stewardship and Regulatory Compliance ** **Intern** to join our ... **APM Product Stewardship and Regulatory Compliance ** team! This position will report directly to the **APM** ** Product Stewardship Manager** . Position… more
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