- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics expertise supporting delivery of small molecule, peptides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …specifically GLP/GCLP studies.Partners with Audit and Compliance QA function to develop compliance and risk criteria, in order to assure compliance with ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director , US Market Access Contracting sits within the National Contract Operations and Supply Chain Team (NCOSC), which delivers best-in-class, ... and Infusion companies for our Company's commercial and government business.-The Director , US Market Access Contracting reports to the Executive Director… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory / Risk Management, Quality Assurance, Medical Affairs, Translational ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. Work with the business users… more
- Merck & Co. (Upper Gwynedd, PA)
- …or regulatory working teamsSuccessfully collaborate and lead resolution of regulatory , reputational (ie public relations), compliance and other asset issues ... Job DescriptionThe Global Director Medical Affairs (GDMA) Oncology Assets & Pipeline...advances. The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset management issues.This is… more
- Merck & Co. (North Wales, PA)
- …Global Marketing, Data & Analytics, Policy, Payer Marketing, Global Communications, Regulatory , Legal/ Compliance Partner with other Product Marketing Owners to ... to join our US marketing team as the Associate Director , Product Marketing Owner - HCC / Ecosystem for...presence Preferred Skills : Understanding of US commercial and regulatory requirementsFamiliarity with agile tools like Jira and MuralNOTICE… more
- Merck & Co. (North Wales, PA)
- …with International Pharmacovigilance community and external customers to ensure regulatory compliance for both expedited and periodic reports.Collaborate ... Collaborate with internal and external stakeholders with processes that ensure compliance with local and global PV regulations.Ensure that PV activities are… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...The successful candidate will be responsible for resourcing planning, risk assessment strategies, talent development, and partnering to build… more
- Merck & Co. (Rahway, NJ)
- …The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …Experience and Skills: Knowledge of Investigational drug regulatory requirementsAudit experience: safety, environmental, compliance /qualityUnderstanding ... FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing,...of growth.Familiarity with US and EU GMP and Safety compliance regulations.Desire and willingness to learn, contribute and lead… more
- Merck & Co. (Rahway, NJ)
- …of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results, document ... disclosure, and data sharing with external researchers. The Executive Director in Medical Writing will be responsible for overseeing clinical trial data… more
- Merck & Co. (Durham, NC)
- Job DescriptionAs the Vaccine Automation Director , you will be the primary point of contact for the HPV IPT for all digital implementations, support, and ... the liaison between above site DMO and the site clients.- The Vaccine Automation Director works with the HPV IPT, Supply Chain, and Technical Operations site leads… more
- Merck & Co. (Rahway, NJ)
- …and implement robust SAP security policies, procedures, and controls.Ensure compliance with regulatory requirements and industry best practices.Manage ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Insmed Incorporated (San Diego, CA)
- …represent Insmed Gene Therapy as subject matter expert during external and internal regulatory submissions and compliance inspections. Travel will be required to ... and Best Medium Workplaces™ lists.OverviewJoin the Technical Operations team as Associate Director of MSAT where you will support pipeline programs that change… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols and reportsServe as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director , Global Process Validation as part of the Technical Operations team based… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …internally and with external parties. Ensure that all employees are in compliance with all contract requirementsSupport the Associate Director Global Strategy ... Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and Operations. In… more
- Merck & Co. (Rahway, NJ)
- …the company's strategy; this includes a deeper knowledge of internal controls, business compliance , and risk management. Individuals will be based in the global ... develop a breadth of experience including finance, accounting, analytics, risk management, and special project opportunities.Corporate Audit and Assurance Services… more
- Novo Nordisk Inc. (Boulder, CO)
- …Lead on site emergency coordinators Conduct routine safety observations to ensure compliance with regulatory agencies, company environmental, health, and safety ... with local regulatory agencies preferred Familiarity with technologies to ensure compliance Ability to take necessary steps to ensure a safe work environment for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Excellence for Scenario Planning and Modeling. The Advisory is led by a director and structured to act as a hub, bringing together cross-functional teams such as ... of our strategic direction. Relationships The position reports to the Director , Strategic Pricing and Contracting - Advisory. The individual will partner… more
