, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo... leader. Review and approve Vendor invoices, including investigator grants and pass through costs. Ensure study budget...
to protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. Leadership of external... literature and acts as a therapeutic area resource. Ensures budgets, timelines, compliance requirements are factored...
. This position requires a depth of understanding and significant experience in GCP and compliance, leadership, and communication... Practice (GLP) and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with our Company's Standard...
to publication planning and evidence strategy development. Support study Investigator meetings and/or Advisory Boards. Maintain... instances of complaints/adverse events from literature to Global Clinical Health (GCH). A Day in the Life Write and edit...
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the... their skills. Associate Director, Medical Safety Science reports to Head of Global Medical Safety Science. Under the direction...
) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide.... Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site...
) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide.... Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site...
of Development Quality. Collaborate with global program teams to ensure protocol, procedural, GCP / regulatory compliance... documents (INDs, manuals, study plans, etc.) for compliance with existing policies and procedures, ICH GCP and applicable global...
consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates... in alignment with the therapeutic study Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance...
, and closeout visits at research sites in compliance with the approved protocol; Communication with the medical site staff... including coordinators, clinical research physicians, and their site staff; Verify adequate investigator qualifications...
documents in compliance with Federal Regulations, including protocols, study reports, relevant sections of investigator..., all with a personal touch. For more information, visit https://global.allerganaesthetics.com/. Follow Allergan Aesthetics...
and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall... data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues...
to protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. Leadership of external... literature and acts as a therapeutic area resource. Ensures budgets, timelines, compliance requirements are factored...
. This position also requires management of global oncology research within the Hematology/Oncology department. The Research Nurse... as a liaison between the patient, investigator, Institutional Review Board(IRB) and sponsor in carrying out the RN responsibilities...
for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff... Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff...
-based decision making to execute these key deliverables in compliance with global regulations and internal processes.... This role represents GPS Safety Science internally and externally at a global level and functions as an authoritative...
, Medical Information and Commercial Operations) while maintaining full compliance with relevant company, industry, legal... of all governance processes. We are an innovative global healthcare company, committed to transforming the lives of people...
with the global Medical Affairs team and cross-functionally with all relevant regional colleagues. Duties... and medical affairs strategies and tactics including the development and implementation of investigator-initiated studies (IIS...
) while maintaining full compliance with relevant company, industry, legal and regulatory requirements Demonstrate operational... understanding and risk management by ensuring excellence in execution of all governance processes. We are an innovative global...
to be the global leader in radiopharmaceuticals . The Senior Medical Director - Clinical Development has responsibility... and CROs to design and implement clinical studies Contribute to writing of protocols, investigator brochures, clinical study...