- Merck (Upper Gwynedd, PA)
- …point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the ... (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations) + Provide clinical… more
- ICON Clinical Research (Blue Bell, PA)
- …+ Oversee statistical activities that support ICON's interactions with clients and regulatory agencies + Review and approve statistical methods sections of study ... internal processes or create new guidance **Your profile:** + Master's degree OR PhD in Biostatistics, Statistics, or a related field + 9+ years of biostatistical… more
- Sumitomo Pharma (Harrisburg, PA)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… more
- J&J Family of Companies (Spring House, PA)
- …by generating hypotheses and investigative strategies. + Accountable for global regulatory nonclinical documents and health authority responses to support clinical ... + Maintain scientific depth and knowledge in competitive intelligence and regulatory landscapes for assigned projects. + Communicate effectively with stakeholders,… more
- System One (Pittsburgh, PA)
- …figures, and listings (TFLs) for clinical trial publications and regulatory submissions. + Collaborate with cross-functional teams, including clinical investigators, ... accessible manner to stakeholders. + Ensure all statistical work complies with relevant regulatory guidelines (eg, FDA, EMA) and Good Clinical Practices (GCP). + Use… more
- Merck (Upper Gwynedd, PA)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- PNC (Pittsburgh, PA)
- …Manuals, policies and procedures accurately reflect current laws, rules, other regulatory requirements and management intent. Oversees regulatory examinations ... including the coordination of interviews and information requests from regulatory agencies. Independently challenges analyses, reviews and recommendations. +… more
- Teva Pharmaceuticals (West Chester, PA)
- …to make a difference with. **The opportunity** The Senior Manager in Global Regulatory Medical Writing writes and edits clinical regulatory documents, including ... fundamental accountability, provides strategic supervision, and planning assistance for clinical regulatory documents. + Writes and edits clinical regulatory … more
- Teva Pharmaceuticals (West Chester, PA)
- …people to make a difference with. **The opportunity** The Director, in Global Regulatory Medical Writing, may write and edit clinical regulatory documents, ... and extensive accountability, strategic vision, and planning for clinical regulatory documents. **Travel Requirements** : International and domestic **Location** :… more
- PNC (Pittsburgh, PA)
- …Manuals, policies and procedures accurately reflect current laws, rules, other regulatory requirements and management intent. Oversees the management of ... regulatory examinations and inquiries, including the coordination of interviews...degree. Higher level education such as a Masters degree, PhD , or certifications is desirable. Industry experience is typically… more