- 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
- 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
- AbbVie (Philadelphia, PA)
- …advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs . Provides timely and accurate reviews of promotional materials in ... accordance with established policies and practice standards, including regulatory guidelines to meet customer needs. + Provides input into externally facing… more
- Takeda Pharmaceuticals (Exton, PA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... and compliance with regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify … 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
- Merck (North Wales, PA)
- …Scientific Leaders; and ensure all Scientific Leader engagement activities comply with regulatory , legal, and ethical standards + Commercial lead in driving engaging ... Vaccines Franchise brands at Congresses; identifying strategic congresses for Global support, including key regional congresses, aligning team activities, and… 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
- Takeda Pharmaceuticals (Exton, PA)
- …potential issues. POSITION ACCOUNTABILITIES: + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... the US Medical team, you will report to the Director , Ad/Promo Regulatory Review. You will be... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Merck (Philadelphia, 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 (Philadelphia, 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
- CSL Behring (King Of Prussia, PA)
- …also partner with teams from Global Commercial Development, Clinical Research and Regulatory Affairs to ensure North America is represented on all future ... **CSL Behring is seeking a Sr. Director , New Product Planning & Evidence Generation (US...multiple teams and people including marketing leadership, US Medical affairs , US Health Care Systems teams, global … more
- Teva Pharmaceuticals (West Chester, PA)
- Director , Clinical Statistics Date: Sep 19, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: 57783 **Who we ... and new people to make a difference with. **The opportunity** The Director , Clinical Statistics is a skilled statistician with significant experience in drug… more
- Merck (Philadelphia, 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
- CSL Behring (King Of Prussia, PA)
- …refining and improving standards for these deliverables. + Collaborate with R&D, Regulatory Affairs , Medical Affairs , Marketing, and other partner ... **Role Overview:** The Executive Director of Global Market Access for Pipeline Assets will be responsible for shaping and implementing market access strategies… more