. This position will be responsible for auditing/reviewing regulatory submissions, working closely with the Regulatory Affairs...Job Description The QA Associate Director, CMC Regulatory Submission QC and Audit, is responsible for the audit...
to and from cross-functional teams and GRA leadership. Counsels and advises senior management on status of global Regulatory Affairs...-functional team and work effectively in a matrix environment Demonstrated technical expertise in regulatory affairs science...
as needed Counsels and advises or seek for alignment with GRA leadership on status of global Regulatory Affairs strategies, critical..., supervising junior regulatory associates and GRA fellows. Knowledge and Skills: Experienced in Regulatory Affairs strategy...
in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field... of multi-product global regulatory CMC strategies for investigational and marketed products. This role is accountable for the...
Branch Operations Manager, North Boston, MA Country: USA Job Function Description: Responsible for the... regulations. May participate in community affairs to enhance the company's visibility and discover new business opportunities...
. Must have strong knowledge of regulatory affairs, research ethics and the responsible conduct of research. REQUIRED COMPETENCIES...Responsibilities The Research Project Manager will work independently under general supervision of a more senior...
Job Title Manager Health Economics & Outcomes Research Job Description You will generate HEOR real-world evidence... Affairs, Marketing, and Market Access teams to execute strategic HEOR activities to support the successful market access...
with colleagues and partner within Regulatory Affairs, Clinical Operations and other groups as needed Willingness to travel... Quality Assurance Manager will oversee GCP activities across various areas of development, ensuring compliance, and quality...
management experience within Medical Affairs, Clinical Research, Regulatory, CMC, Marketing or other drug development related... of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Global Medical Program Manager...
and continuous improvement. Collaboration and Communication: Collaborate closely with Regulatory Affairs, Process, Lifecycle...This is what you will do: The Manager, PRC Coordinator, Promotional Review and Operations (PRO) is a dynamic leader...
Operations, Clinical Research, Quality Assurance, Global Patient Safety & Risk Management (GPSRM), and Regulatory Affairs; CROs...Job Title: Principal Clinical Data Manager Job Location: Cambridge, MA, USA Job Location Type: Remote...
Assurance, Regulatory Affairs) and with external safety teams in Contract Research Organizations (CROs) and partners. The...Job Title: Senior Manager, Pharmacovigilance (PV) Operations Excellence Job Location: Cambridge, MA, USA...
Branch Operations Manager, Washington Park, Roxbury, MA Country: United States of America USA Job Function... and federal and state regulations. May participate in community affairs to enhance the company's visibility and discover new...
, Regulatory Affairs, Drug Safety, and Medical Affairs. Our products are utilized by 40 out of 50 major biopharmaceutical companies... We are looking for a rockstar Manager/Sr. Manager of Demand Generation to be part of a hungry and humble team of marketers. The ideal candidate...
Manager, GCP Compliance Location: Cambridge, MA About the role: As a Senior Manager, GCP Compliance, you will provide... from regulatory inspections and quality investigations. Participate in cross-functional continual improvement projects to maintain...
guidelines including, but not limited to, medical and regulatory affairs, drug development, FDA and regulatory guidelines (e.g...Job Description General Summary: The Grants Manager is responsible for the overall management of the grants...
Branch Operations Manager, Charlestown, MA Country: United States of America USA Job Function... and federal and state regulations. May participate in community affairs to enhance the company's visibility and discover new...
. Maintaining a core understanding of the medical device regulatory process in collaboration with Regulatory Affairs and providing... progression through design phases. Coordinate with cross-functional teams, including R&D, Regulatory Affairs, Quality...
for External Affairs, the State Relations Manager will assist with all aspects of state government relations for Northeastern... in Massachusetts and across the university’s network of U.S. campuses. The State Relations Manager will develop relationships...
start up team and regulatory affairs Ensures regional and country information in study systems and tools is entered and up...Job Title: Regional Clinical Study Manager - Oncology/ Solid Tumor Job Location: United States Job Location...