- Taiho Oncology (Princeton, NJ)
- … documents related to clinical studies as outlined by the manager . + Attend study site initiation visits (SIV) and provides therapeutic area, compound, ... (IB), informed consent forms (ICF), case report forms (CRF), Clinical study report (CSR), NDA/MAA registration documents,...Institutional Review Boards/ Ethics Committees (IRBs/ECs) relevant to the studies . + Review and sign off on clinical… more
- Takeda Pharmaceuticals (Lexington, MA)
- …best of my knowledge. **Job Description** About the role: Join Takeda as a Senior Manager , US Medical Information and Review where you will deliver high-quality, ... to include development of standard written and verbal responses, including Clinical Dossiers, Letters and Frequently Asked Questions (FAQs), and periodic review… more
- Georgetown Univerisity (Washington, DC)
- …visit, the Senior Research Coordinator responsible for conducting the entire study visit for each patient, ensuring that the protocol is followed, which requires ... to communicate and coordinate with such departments effectively. The Senior Research Clinical must be capable of...for this position will is responsible for coordinating 7 studies , which will be conducted at the Georgetown University… more
- Philips (Bothell, WA)
- ** Senior Clinical Research Associate, Oral Healthcare** The Senior Clinical Research Associate oversees site performance and compliance with safety and ... start-up and management tasks, particularly during periods of increased workload. Act as study manager , when needed, with guidance and oversight. + Contribute to… more
- AbbVie (North Chicago, IL)
- …Lake County, IL; Irvine, CA; San Francisco, CA or Florham Park, NJ The Senior Manager , Statistics provides statistical leadership to support the research and ... for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs. The... trials, patient safety, and global medical affairs. The Senior Manager works independently in partnership with… more
- AbbVie (North Chicago, IL)
- …monitoring and regulatory submissions, as well as post-marketing access. As a Senior Manager , Statistics you will provide statistical leadership to support ... include clinical trials, patient safety, and global medical affairs. Senior Managers works independently in partnership with experts in multiple disciplines to… more
- Regeneron Pharmaceuticals (Warren, NJ)
- The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and ... Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds + Participate in… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs ... related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure… more
- Regeneron Pharmaceuticals (Warren, NJ)
- … Clinical Scientist; Member of the Clinical Study Team and Global Clinical SubTeam + Line Manager for CS team and serves as key functional advisor or ... studies and ensures scientific integrity and interpretation of study data of a clinical development program....and late phase development. The Director reports to the Senior Director Clinical Sciences and collaborates closely… more
- AbbVie (North Chicago, IL)
- …Boards (ALBs), and who lead Clinical Strategy Teams (CSTs) and clinical study teams, to ensure high-quality, cross-functionally-aligned program (ie, ... interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other… more