- Merck & Co. (North Wales, PA)
- …results, document disclosure, and data sharing with external researchers. - The Director , Disclosure Quality & Compliance is responsible for independently ... and negotiating with stakeholders across the organization. - The responsibilities of the Director , Disclosure Quality & Compliance are to: - Apply advanced… more
- Merck & Co. (Houston, TX)
- Job DescriptionRole SummaryThe Regional Medical Scientific Director is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in ... questions about Company products. The work of an Regional Medical Scientific Director is aligned to: Scientific Exchange, Research, Scientific Congress Support, and… more
- Formation Bio (New York, NY)
- …closeout. This role ensures that trials are executed efficiently, on time, and in compliance with all regulatory requirements. The Director will manage a team of ... bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Trial Management is responsible for leading and overseeing… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic ... clinical programs across various therapeutic areas and phases (I-IV), ensuring compliance with global regulations, delivering on timelines and budgets, and driving… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: The Associate Director , Data Management Processes, Training and Inspection Readiness, is accountable for ... and/or implement any changes that are required to department training, compliance , or operations. Ensure appropriate Data Management representation and contribute to… more
- Formation Bio (New York, NY)
- …product release, stability programs, change management, and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at ... bring new treatments to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA strategy and execution… more
- Formation Bio (New York, NY)
- …including consulting statisticians and CROs, ensuring high-quality statistical deliverables and compliance with GCP and regulatory standards. About You Ph.D. ... the PositionFormation Bio is seeking a highly skilled and experienced Senior Director , Biostatistics to join our dynamic team. This critical role will report… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting ... data collection and reporting.Proficient in database entry systems.Strong knowledge of GCP and GLP.Thorough understanding of clinical research and clinical trial… more
- Merck & Co. (Rahway, NJ)
- …- Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices ( GCP ) is highly desirable. - Preferred Experience and Skills: - - Proficiency ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include:Collaborating cross-functionally in the development of ... scientists.Core Skills Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing priorities with good… more
- Takeda Pharmaceuticals (Boston, MA)
- …readiness and process adherence into ways of working. + Partner with R&D Quality and GCP Compliance Management to develop GCP inspection strategy in support ... empower you to shine? Join us as an Associate Director , GCP Excellence in Clinical Trials based... GCP Excellence in Clinical Trials and with GCP Compliance Management to prepare and facilitate… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Associate Director , Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is a key position that is responsible ... for the effective management of GCP , GVP and GLP inspections. The GDQIM IML will...guidelines including the management of significant/complex quality issues and compliance activities. * Extensive experience with participating in, and… more
- Takeda Pharmaceuticals (Boston, MA)
- … GCP Excellence in Clinical Trials based remotely reporting to the Associate Director , GCP Excellence in Clinical Trials. At Takeda, we are transforming the ... departmental objectives, representing GCP Excellence globally. Develop and implement GCP Excellence processes to enhance support and compliance , identifying… more
- Danaher Corporation (Austin, TX)
- …System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Director , Clinical Quality and Compliance reporting ... and execution of a robust and global clinical affairs compliance strategy and program including internal GCP ...affairs compliance strategy and program including internal GCP auditing (ie, TMF, SOP compliance , training,… more
- Kelly Services (Bothell, WA)
- …with the company's Quality Management System (QMS) to uphold regulatory compliance . The Senior Director / Director will collaborate cross-functionally ... clinical quality procedural documents, including SOPs and work instructions, to ensure compliance with GCP , GLP, and GVP regulations. * Provide training,… more
- System One (King Of Prussia, PA)
- Job Title: Sr. Director , Clinical Compliance Location: King of Prussia, PA OR Alameda, CA (ONSITE) Type: Direct Hire Overview The Senior Director , Clinical ... are conducted by Clinical staff in accordance with ICH GCP , relevant international and local regulations, requirements, and guidelines,...and guidelines, as well as written standards. The Sr. Director of Clinical Compliance is a key… more
- St. Luke's University Health Network (Allentown, PA)
- …serve, regardless of a patient's ability to pay for health care. The Director , Research Finance and Compliance provides strategic and operational leadership for ... the financial management, regulatory compliance , and long-term sustainability of SLUHN Clinical Trials and...the Code of Federal Regulations (CFR), Good Clinical Practices ( GCP ), Fair Market Value (FMV), sponsor-specific requirements, and all… more
- Takeda Pharmaceuticals (Boston, MA)
- …the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical and Safety Quality Compliance is responsible for ensuring the ... and Statistics, with at least 3 years of experience in GCP Quality/ Compliance . + Advanced knowledge of pharmaceutical development, medical affairs and … more
- Merck (Rahway, NJ)
- …their results, document disclosure, and data sharing with external researchers. The Director , Disclosure Quality & Compliance is responsible for independently ... and negotiating with stakeholders across the organization. **The responsibilities of the Director , Disclosure Quality & Compliance are to:** + Apply advanced… more
- Lilly (Indianapolis, IN)
- …around the world. **Position Overview:** The PR&D Quality System Associate Director provides critical leadership, oversight, and cross functional influence and ... Quality System (QS) are well managed. The PR&D Quality System Associate Director partners cross functionally with the business to implement key quality projects,… more
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