- Merck (North Wales, PA)
- **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, ... as appropriate, and corresponding therapeutic dossiers. + Interacting with global regulatory authorities and diagnostic partners to...devices, the majority of which must be in diagnostic regulatory affairs . Preferred: MS with minimum of… more
- Merck (North Wales, PA)
- …The GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business ... compliant business standards, process maps, and risk management for global processes across GRACS. The GPL actively engages with...+ Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that… more
- J&J Family of Companies (Spring House, PA)
- …recruiting for Associate Director , North America Regulatory Lead in Global Regulatory Affairs , supporting programs in the Immunology Therapeutic ... At Johnson & Johnson, we all belong. The Associate Director , Regulatory Affairs will be...strategy through participation in product-related teams. + Provides regional regulatory input to the Global Regulatory… more
- Merck (North Wales, PA)
- …standards and policies and business objectives. Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... **Job Description** Reports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Merck (North Wales, PA)
- …including the related SOPs and Execution resources. The incumbent is accountable to Sr. Director of Business Process and Systems with input from VP, CSRM as needed, ... contributing functional areas and process governance committees. Works with Sr. Director for Business Process and Systems, CSRM to develop and implement… more
- J&J Family of Companies (Horsham, PA)
- …partners with individuals in Gastroenterology TA and other groups inside and outside Medical Affairs (eg Biostats, GCO, Regulatory Affairs , QA and QC) to ... Medical Director , Gastroenterology Therapeutic Area - Medical Affairs...with other GI team members in the US and Global Medical Affairs Organization, as well as… more
- J&J Family of Companies (Spring House, PA)
- …* MA/MPH preferred **Required:** * 5 years in the pharmaceutical industry * 2 years in Regulatory Affairs or Policy * 2 years of direct or indirect management of ... Director , Regulatory Policy and Intelligence Research...* Experience at Health Authority * Understanding of the global regulatory environment, including in US, EU,… more
- J&J Family of Companies (Horsham, PA)
- Associate Director , Global Commercial Insights and Analytics, Autoantibody (Horsham, PA) - 2406206641W **Description** Johnson & Johnson is seeking a Associate ... Director , Global Commercial Insights and Analytics, Autoantibody...collaborating and communicating cross-functionally with competitive intelligence, finance, medical affairs , regulatory and other key functions +… more
- Pfizer (Collegeville, PA)
- …lead or participate in manuscript, abstract and poster development. + Safety and Regulatory Support: Provide regional medical affairs support and leadership for ... in Breat Cancer Franchise on behalf of Asset Medical Affairs team. + Provides strategic medical input for breast...at each lifecycle stage. + Partnership cross-function partners within Global team + Promotional Materials Development and Review: +… more
- Merck (North Wales, PA)
- …above-product public policy issues and geo-political changes that will impact our global business. The Director independently and proactively identifies risks ... Director , Policy Development, Strategy, and Capabilities, the AVP, and VP Global Public Policy. Reporting to the Executive Director , Policy Development &… more
- Merck (North Wales, PA)
- …and must be able to work with all levels of management within and outside of Global Regulatory Affairs and Clinical Safety (GRACS). + Interact closely with ... **Job Description** Under minimal guidance of the Executive Director / Director /Associate Director , Pharmacovigilance (PV)... regulations. + The incumbent must be knowledgeable of global regulatory requirements at a general level… more
- Merck (North Wales, PA)
- …Associate Director will independently develop and execute a company-wide global policy advocacy strategy, create business cases for and manage budgetary ... **Job Description** **Position Description:** **Associate Director , Policy Advocacy** The Associate Director ,...Policy Advocacy serves as the senior expert in the Global Public Policy (GPP) organization on designing and implementing… more
- Merck (North Wales, PA)
- …the Policy Development Director in conducting analyses to produce reports on global policy environment as requested by Executive Director , AVP, other GPP LT ... **Job Description** **Position Description:** **Associate Director , Policy Strategy and Capabilities** The Associate ...to ensure that they are fit for purpose for global , regional, and country policy planning and activity tracking.… more
- Merck (North Wales, PA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Director may… more
- Merck (Upper Gwynedd, PA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... **Job Description** The Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA) ... @Olympus.com, it is likely not legitimate._ **Job Description** The Complaint Director is responsible for establishing and maintaining a complaint handling process… more
- J&J Family of Companies (Horsham, PA)
- …experience. + Relevant experience in the pharmaceutical industry (eg, Regulatory Affairs , Clinical, Medical Information, Pharmacovigilance) including at ... Associate Director , RA Labeling Product Leader (1 of 2)...with external partners. + Contribute to and implement the global labeling strategy, including demonstrating an understanding of competitors… more
- Organon & Co. (Plymouth Meeting, PA)
- …innovation and promotional regulatory strategy in collaboration with Commercial, PRT, Global Regulatory Liaisons, Medical Affairs and Worldwide Product ... + Support BD due diligence efforts and define promotional regulatory risks of asset acquisitions and partnerships. + Leads...live their best lives. We are a $6.5 billion global healthcare company focused on making a world of… more
- Merck (North Wales, PA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …work closely with other functions such as Operations, Service, Repair, Post Market Quality, Regulatory Affairs , Medical Affairs and others to ensure that the ... following roles will report into this role directly: Executive Director , Manufacturing Quality (Japan), Director of Quality...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more