- Greene Tweed (Kulpsville, PA)
- …: + Creates a detailed, finite production schedule by work center across the global business circuit and plant sites + Ensures a frozen schedule one week in ... of raw materials, semi-finished and finished parts to fulfill internal and external demand + Monitors adherence to production...messages + Validate data including but not limited to lead times, dates in system, and capacities drive corrective… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …information requests. Functions as a team member/ leader in collaboration. + Lead /Manage special assignments/ projects with Global MDR Submission or across ... . **Job Description** Responsible for the review of medical device global complaints and coordinate the resolution of complex complaints (For example:… more
- CSL Behring (King Of Prussia, PA)
- …that make a meaningful difference worldwide. Could you be our next Senior Director, Global Clinical Program Lead , Cardiovascular? The job is in our King of ... accountable for the design and execution of the clinical strategy to support the development of a medicine, aligned with the Project Strategy Document (PSD) and the… more
- CSL Behring (King Of Prussia, PA)
- …of the data on ongoing R&D strategies and provides support in defining the development strategy. + " Lead Author" or "Contributing" Author for key study ... week. You will be a critical role within Clinical Development . You are accountable for the design and execution...required cross-functional Delivery Teams (DT) This position is a " Lead Author" or "Contributing Author" for: + key study… more
- Organon & Co. (Plymouth Meeting, PA)
- …and Early Development (TMED) Department at Organon. The Clinical Pharmacology Lead also will be responsible for the rationale, study design and oversight of ... the most up-to-date literature and regulatory guidance and support the approved early development plans. The Clinical Pharmacology Lead will serve as the medical… more
- CSL Behring (King Of Prussia, PA)
- …experience to actively contribute to an innovative, scientifically sound, global , integrated regulatory vision/strategies for assigned product/s with a ... delivery of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional,… more
- CSL Behring (King Of Prussia, PA)
- …high quality, regulatory compliance, and operational efficiency, in alignment with global clinical development strategies. Operating within a matrix environment, ... be our next Senior Site Management and Monitoring Oversight Lead ? The job is in our King of Prussia...this role partners with internal stakeholders and external service providers to develop and… more
- CSL Behring (King Of Prussia, PA)
- …across clinical programs. Operating within a matrixed environment, the Senior TMF Lead collaborates with internal teams and external partners to drive ... difference worldwide. Could you be our next Senior TMF Lead ? The job is in our King of Prussia...Support audits/inspections and resolutions of findings. Support in the development of new SOPs, guidelines etc and/ or participate… more
- CSL Behring (King Of Prussia, PA)
- …that make a meaningful difference worldwide. Could you be our next Director Statistical Programming Lead ? The job is in our King of Prussia, PA office. This is a ... Director Programming. You will provide leadership and expertise in driving the development and maintenance of the CSL statistical programming capabilities which is… more
- Greene Tweed (Kulpsville, PA)
- …in innovation, infrastructure, and talent-and delivers results. **What You'll Do** + Lead compound development projects aligned with customer needs, new markets, ... Tweed, innovation is more than a goal-it's a mindset. As a global leader in high-performance materials for demanding applications across Aerospace, Energy,… more
- Organon & Co. (Plymouth Meeting, PA)
- …**The** **Position** The Non-Clinical Safety Assessment Representative within the Non-Clinical Development (NCD) team, is accountable for the representation of the ... non-clinical safety function (ie, toxicology) on asset development teams (ADTs). This position will report to the...This position will report to the Non-Clinical Safety Assessment Lead . The NCD team is comprised of non-clinical drug… more
- Organon & Co. (Plymouth Meeting, PA)
- …global regulatory submissions. **Responsibilities** + Provide support for the Biopharmaceutics Lead on early clinical development programs to ensure optimal ... guidance on the pharmacokinetic performance of drug products during formulation development and the drug product life cycle, including interpretation of relevant… more
- CSL Behring (King Of Prussia, PA)
- …& Oversight** + Lead regional clinical operations strategy aligned with global clinical development goals. + Ensure monitoring and site management activities ... smooth clinical trial execution. **Cross-Functional Collaboration** + Collaborate with internal stakeholders across clinical development , regulatory, and data… more
- CSL Behring (King Of Prussia, PA)
- …with the Head of Global Regulatory Policy and Intelligence, GRASP, internal global regulatory and safety teams, and Competitive Intelligence (CI) team. ... global regulatory changes, guidelines, and trends affecting drug development , approval, and post-marketing requirements. Maintain and update a regulatory… more
- CSL Behring (King Of Prussia, PA)
- …is onsite three days a week. You will hold work closely with the CDT Lead and other Clinical Representatives in performing delegated tasks in support of the clinical ... development program as dictated by therapeutic area/ project needs....clinical data and the writing of clinical study reports, internal and external scientific meeting presentations and peer-reviewed publications,… more
- CSL Behring (King Of Prussia, PA)
- …thorough understanding of pipeline status and strategic positioning within the Portfolio Development & Commercialisation (PD&C) Framework. + Lead the analysis ... PRISM Members, TA Co-Leads, GPLs, Portfolio Decision Strategy Director, Governance Lead , Commercial Development , Portfolio Development , Business … more
- CSL Behring (King Of Prussia, PA)
- …work, budgets, and contracts with external service providers to support CSL's global clinical and portfolio development needs. This individual contributor role ... + Maintain organized and up-to-date contract documentation in line with internal requirements and industry regulations. **Financial and Operational Support** +… more
- CSL Behring (King Of Prussia, PA)
- …will lead components of statistical contribution to a clinical development program. The Principal Biostatistician implements the statistical strategies for the ... to study design and data analysis for clinical trials and regulatory submissions. Lead components and fully support Biostatistics conduct in study design, protocol … more
- Organon & Co. (Plymouth Meeting, PA)
- …tactics; and proactively and compliantly collaborating with Commercial and other internal stakeholders. **Responsibilities** + Build, lead , manage, develop, and ... and document on-going coaching, assist with creation and execution of development plans, and monitor performance against expectations. + Proactively and compliantly… more
- CSL Behring (King Of Prussia, PA)
- **The Opportunity** As the Senior Director, Medical Affairs, you will lead the development and execution of Medical Affairs strategies and tactics to support the ... as the medical and scientific expert and represent current US medical practice to internal CSL Behring stakeholders. You will have a high awareness of patient needs,… more
