- CSL Behring (King Of Prussia, PA)
- **The Opportunity:** Reporting to the Global Head of Enterprise Risk Management , as the **Director,** **Enterprise Risk Management ** , you will be ... operational and tactical plans to ensure that the Enterprise Risk Management Framework (ERMF) including the ...matters at CSL Behring!** R-262602 CSL makes all employment decisions without regard to race, color, religion, national origin,… more
- CSL Behring (King Of Prussia, PA)
- …that make a meaningful difference worldwide. Could you be our next Senior Site Management and Monitoring Oversight Lead? The job is in our King of Prussia PA, ... days a week. You will report to the Senior Director Head of Site Management & Monitoring. You will be accountable for the strategic and operational oversight of… more
- Merck & Co. (North Wales, PA)
- …for our patients, partners, and colleagues.As a Technical Product Manager for the Compliance, Risk , Quality, & Vendor Management product you will spend a lot of ... across the organization. Candidate will be accountable for the entire Compliance, Risk , Quality, & Vendor Management product from the prioritization and… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …lead preparation of regulatory submissions (eg, pre-IND, IND, BLA).Contribute to risk assessment of new and ongoing programs, including off-target effects, ... such as Pharmacology, CMC, Regulatory Affairs, Clinical, and Program Management .Maintain up-to-date knowledge of evolving regulatory guidelines and scientific… more
- CSL Behring (King Of Prussia, PA)
- …trusted advisor to functional heads on governance best practices and operational risk management . Performance Monitoring & Continuous Improvement + Define, ... + Deep understanding of R&D processes, regulatory environments, and operational risk management . + Demonstrated leadership and collaboration skills, with… more
- CSL Behring (King Of Prussia, PA)
- …cross-functional Delivery Teams (DT) including but not limited to the Safety Management Team (SMT), the Benefit- Risk Assessment Team (BRAT), the Biomarker ... capabilities in a matrix environment + - Demonstrated stakeholder management skills including risk mitigation + -...matters at CSL Behring!** R-263497 CSL makes all employment decisions without regard to race, color, religion, national origin,… more
- CSL Behring (King Of Prussia, PA)
- …of new tools and workflows that enhance operational efficiency and data integrity. ** Risk Management & Compliance Monitoring** Conduct risk assessments ... **TMF Oversight** Design and implement operational strategies and study management plans that support TMF completeness, quality, and compliance **Inspection… more
- CSL Behring (King Of Prussia, PA)
- …ad/promo team of reviewers. Provide mentorship, professional development, and performance management . - ** Risk Assessment:** Identify and mitigate regulatory ... execute global regulatory ad/promo strategies to support product commercialization, lifecycle management , and expansion into new markets. - **Regulatory Review &… more
- CSL Behring (King Of Prussia, PA)
- …modelling and innovative decision-support, while ensuring comprehensive portfolio data management , performance monitoring and adherence of portfolio standards. Role ... monitor and communicate the impact of internal and external events and decisions across short-, mid-, and long-term horizons, ensuring a thorough understanding of… more
- CSL Behring (King Of Prussia, PA)
- …Plasma strategy. + Assures that processes are in place for effective Idea Management + Develops plans for initiatives, based on the OE strategic roadmap, designed ... targets to ensure cost-effectiveness. + Develops and executes the business process management function to enable process management capability + Aligns OE… more
- CSL Behring (King Of Prussia, PA)
- …cross-functional Delivery Teams (DT) including but not limited to the Safety Management Team (SMT), the Benefit- Risk Assessment Team (BRAT), the Biomarker ... not limited to meeting coordination and documentation, decision making, and stakeholder management .** **ensuring that the program is conducted in alignment with CSL… more
- CSL Behring (King Of Prussia, PA)
- …ad/promo team of reviewers. Provide mentorship, professional development, and performance management . - ** Risk Assessment:** Identify and mitigate regulatory ... and global regulatory ad/promo strategies to support product commercialization, lifecycle management , and expansion into new markets. - **Regulatory Review &… more
- CSL Behring (King Of Prussia, PA)
- …Monitor, track and analyze global PV regulations, safety reporting requirements, and risk management guidelines. Maintain and update safety intelligence database ... database with timely and accurate information. Provide strategic insights and risk assessments to internal stakeholders based on evolving regulatory landscapes.… more
- CSL Behring (King Of Prussia, PA)
- …and project teams to embed decision quality process that guide strategic decisions and effective management of portfolio risks, directly influencing how ... at stakeholder engagement to ensure balanced and widely supported decisions . **Main Responsibilities & Accountabilities** **Strategic Decision Consultation and… more
- CSL Behring (King Of Prussia, PA)
- …in a consistent manner, that meets the needs of the organization for risk management , budget, critical path / timelines and resourcing issues. **Qualifications ... **Position Description** **Summary** Lead the Project Management Office for R&D **Main** **Responsibilities & Accountabilities** - -Leads PM office which will… more
- Merck & Co. (North Wales, PA)
- …and Policy, Licensing and Evaluation (PEL).Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements for facility design, ... and ensure team and company adherence to these documents.Develop a risk -based approach to prioritize USDA compliance requirements for our manufacturing… more
- Merck & Co. (North Wales, PA)
- …way. Define the proper KPIs and measurement plans to deliver data driven decisions and optimizations Be responsible for working in an Agile setting along with ... intervention points and business solutions - to drive business results Demonstrated change management skills and able to establish action plans for self and others… more
- Merck & Co. (North Wales, PA)
- …to hear from you.Why this role matters:Influence design and scale-up decisions for freeze-drying cycles and integrated fill-finish operations that affect product ... standards across R&D and commercial manufacturing.Drive continuous improvement and risk -based technical governance at this new lyophilization site.Key Responsibilities:Provide… more
- Organon & Co. (Plymouth Meeting, PA)
- …in clinical phase through initial product registration and post approval life cycle management for the assigned portfolio of small molecule or biologic products. The ... sound regulatory insight, ensuring a balanced approach to regulatory risk , understanding the impact to the business, utilizing regulatory...this will be managed, the key risks and tradeoff decisions that are required. + Responsible to ensure that… more
- Towne Park (Media, PA)
- …Ensures claims are reported timely and accurately and cooperates with the Risk Management department to resolve claims. Consistently follows the progressive ... organizational chart therein, responsible for account performance in financial management , guest satisfaction, and client satisfaction and business development… more
