- CSL Behring (King Of Prussia, PA)
- …manufacture and commercial launch. Interface with other disciplines including Global Regulatory Affairs , Project Management, Operations and Commercial ... is responsible for the leadership and co-ordination of all regulatory GxP inspections for the R&D teams and across...Pharmacovigilance and Safety. Responsible for the execution of the global audit program for R&D, including internal systems and… more
- Organon & Co. (Plymouth Meeting, PA)
- …agile manner. + Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse late-stage ... **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal Scientist (Associate Director) is… more
- West Pharmaceutical Services (Exton, PA)
- …Project Management (RPM) role is responsible for management of regulatory affairs projects associated with West's global portfolio of medical devices, ... quality assurance, clinical affairs , labeling, to align on deliverables for global submissions, establish key regulatory positions, and to ensure product… more
- J&J Family of Companies (Spring House, PA)
- …closely with the Global Regulatory Leader (GRL) and partners across Global Regulatory Affairs as well as Project Management, Medical Writing, ... playbooks, scenario evaluation and business case development). + Lead operations with Global Regulatory Team...and lifecycle documents) is required. + Demonstrated understanding of Global Regulatory Affairs processes is… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …it is likely not legitimate._ **Job Description** The Director Scientific Communications, Global Operations plays a central role in the efficient application ... relevant internal stakeholders, such as Commercial (Marketing & Sales), Marketing Communication, Regulatory Affairs , Learning & Development. + Selects & manages… more
- Merck (West Point, PA)
- …discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations ). + Provide ... Operations , Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout research… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Director will build and lead a high-performing team to ensure global operations meet or exceed standards, aligning with regulatory requirements and business ... to meet or exceed requirements for PMS and other global regulatory authorities. Identify, assess, and mitigate...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
- Merck (Upper Gwynedd, PA)
- …Work effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , manufacturing, Business Development ... competitive strategy, target product profile development, health authority interactions, global regulatory filing strategy, launch readiness reviews, organized… more
- CSL Behring (King Of Prussia, PA)
- …stakeholders across the organization such as Clinical R&D, Pharmacovigilance, Quality, Marketing, Global Market Access/HCS, Heads of Medical Affairs in the US ... and International, TA Heads and global medical operations functions *Collaborate with Global Medical Education to ensure staffing of medical information… more
- CSL Behring (King Of Prussia, PA)
- …drug development and manufacturing processes for pharmaceuticals (CMC, non-clinical, clinical, Regulatory Affairs ). **BENEFITS** + Medical, Dental Vision + 401K ... CSL Behring is a global biotechnology leader, guided by a promise to...committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide,… more
- CSL Behring (King Of Prussia, PA)
- …with a multidisciplinary team with members from Marketing, Sales, Medical Affairs , Compliance, Reimbursement, Healthcare Systems and Operations . Some domestic ... to the brand team and interfacing with all US commercial disciplines ( operations , marketing, sales, health care systems, medical affairs , legal, compliance)… more
- CSL Behring (King Of Prussia, PA)
- …key external stakeholders. *Knowledge of relevant business, legal, compliance and regulatory requirements *Familiarity with global regulations and cultural ... **Position Description** **Summary:** *Transformative global role responsible for standardizing our end-to-end procurement-to-pay processes, inclusive of HCP… more
- West Pharmaceutical Services (Exton, PA)
- …Requisition ID: 67473 Date: Oct 15, 2024 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: **_This role is hybrid (3 days onsite) in ... and planet through our sustainability efforts. **Job Summary:** The Principal, Regulatory Affairs , Intelligence, Materials is expected to perform with… more
- Pfizer (Collegeville, PA)
- …and acquisitions, as needed. **Technology/Process Improvement** + Partners with the Clinical Affairs & Operations Team and Platform & Partnerships. The Quality ... quality oversight for implementation of research and studies conducted in the global RWE Platform. This role will coordinate and facilitate quality, vendor oversight… more
- Teva Pharmaceuticals (West Chester, PA)
- …to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. **How you'll spend your day** The Senior Director will ... as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing,… more
- Organon & Co. (Plymouth Meeting, PA)
- …Officer, and is accountable for: + The leadership of the following teams: Global Clinical Development (GCD), Clinical Trial Operations (CTO), Clinical Data ... with senior leaders from other areas. + Leadership of the following teams: Global Clinical Development, Clinical Trial Operations , Clinical Data Sciences, and… more
- Organon & Co. (Plymouth Meeting, PA)
- … operations across the functions (Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs ) and the drug development ... in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.)...live their best lives. We are a $6.5 billion global healthcare company focused on making a world of… more
- CSL Behring (King Of Prussia, PA)
- **Location:** KOP, EU **Summary:** + Responsible for the design and operations of a world-class content supply chain fulfilling the needs of Marketing, Market ... Access, and Medical Affairs at the time of launch and throughout brand...goals in content management, including the evolution from a Global COE to global shared services +… more
- Organon & Co. (Plymouth Meeting, PA)
- …collaboratively with cross-functional colleagues in preclinical science, data science, clinical operations , regulatory affairs , chemistry, manufacturing and ... 2a study protocols, in collaboration with internal (biostatistics, clinical operations ) and external (contract research organization [CRO], bioanalytical and/or… more
- Pfizer (Collegeville, PA)
- …to effectively communicate information and initiatives related to Collegeville site operations and activities, and enterprise outreach and programming. This role ... programs, as well as executing day-to-day site planning, campus operations , data management, and procurement activities. As a Sr...the goals and objectives of the Pfizer Collegeville Site Affairs team. Your focus and ability to meet team… more