- Merck & Co. (North Wales, PA)
- Job DescriptionOur Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, ... submissions, as appropriate, and corresponding therapeutic dossiers.Interacting with global regulatory authorities and diagnostic partners to determine… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe Global Director Medical Affairs (GDMA) Oncology Assets & Pipeline coordinates the development and implementation of the Global Medical ... edge of therapeutic and patient care advances. The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset… more
- Merck & Co. (North Wales, PA)
- …corporate standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... Job DescriptionReports 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 & Co. (North Wales, PA)
- …Leaders; and ensure all Scientific Leader engagement activities comply with regulatory , legal, and ethical standardsCommercial lead in driving engaging presence of ... Vaccines Franchise brands at Congresses; identifying strategic congresses for Global support, including key regional congresses, aligning team activities, and… more
- Merck & Co. (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
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Job DescriptionOur company is a global health care leader with a diversified portfolio...of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Director May… more
- Merck & Co. (North Wales, PA)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Job DescriptionOur company is a global health care leader with a diversified portfolio...and dedicated colleagues while developing and expanding your career.-- Director (Principal Scientist) has primary responsibility for the planning… more
- 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
- Pfizer (Collegeville, PA)
- **ROLE SUMMARY** The Director , Medical Affairs Oncology Digital & AI Innovation will report to the Oncology AI Innovation Head. This is a vital role within the ... acting as an operational business partner across Oncology Medical, International Medical Affairs , and Pfizer US (Medical Platforms) for all digital and AI… 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 ... Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products,...participating in Agency meetings on CMC topics, and executing global initial marketing applications with a line of sight… more
- Organon & Co. (Lansdale, PA)
- …regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation ... **Job Description** **The Position** Reporting to the Executive Director in Organon's Regulatory Chemistry, Manufacturing and Controls (CMC) New Products, the… 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)
- …discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings. + Represents Vaccine Clinical Affairs and may take ... or more vaccine asset programs. In collaboration with Scientific Affairs (SA) Biostatistics group and Clinical Affairs ...Pfizer-sponsored or as Research Collaborations. The CS is a global position and may support all types of Evidence… more
