- Fresenius Medical Center (Waltham, MA)
- …timely reports, both orally and in writing, to the Director of Compliance Investigations and/or senior management regarding the status of investigations. ... **PURPOSE AND SCOPE:** Under the general direction of the VP of Compliance , this position assists with the development, implementation, and continuous monitoring of… more
- Beth Israel Lahey Health (Boston, MA)
- …with physicians, nurses and fellows. Identifies and resolves problems with protocol compliance . Keeps principal investigator and research nurse aware of any ... staff are in compliance with protocols. (essential) + May assist physician investigator in reviewing data from research protocol in order to assess efficacy of… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Investigator , Ethics and Business Integrity, North America **Location:** Cambridge, MA **About the Job** Ready to push the limits of what's possible? ... This position is responsible for conducting comprehensive and objective internal Compliance investigations within the North America Ethics & Business Integrity team.… more
- Lilly (Boston, MA)
- …protocol writing, regulatory documents, CRO interactions, study start up, investigator interactions, data monitoring, health authority interactions, analyses, and ... safety assessment parameters + Work with ExploR&D regulatory personnel to ensure compliance + Serve as Sponsor physician for case-management of SAEs, or provide… more
- Sumitomo Pharma (Boston, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Medical Science Liaison** . The ** Senior Medical Science Liaison** ... drug/brand development. + Identify, initiate, coordinate, evaluate and monitor investigator -sponsored studies intended to support the clinical and scientific… more
- Sumitomo Pharma (Boston, MA)
- …. **Job Overview** The Senior Manager, Pharmacovigilance Scientist serves ... and provide safety guidance and input to key documents, including Investigator Brochures (IBs), informed consent forms (ICFs), protocols, study reports, regulatory… more
- Deloitte (Boston, MA)
- AML Project Delivery Senior Analyst-Project Delivery Senior Analyst- Regulatory, Risk & Forensic Operate Are you an experienced, passionate pioneer in technology ... wants to work in a collaborative environment? As an experienced AML Project Delivery Senior Analyst you will have the ability to share new ideas and collaborate on… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …onsite in our Cambridge, MA office. Fully remote is not eligible._ The ** Senior Clinical Study Lead** (CSL) is expected to operate with high-degree of independence ... study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study...System (CTMS), Trial Master File (TMF) etc. + Ensures compliance with the clinical trial registry requirements + Identifies… more
- Actalent (Boston, MA)
- Job Title: Senior Medical WriterJob Description We are seeking a highly experienced Senior Medical Writer to join our team and contribute significantly to our ... documents, including Protocols & Amendments, Clinical Study Reports (CSRs), Investigator Brochures, and Meeting Briefs. + Work collaboratively across functions… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** ** Senior Scientific Director, Clinical Pharmacology** **Boston, MA** **_OBJECTIVES/PURPOSE_** The ... to execution and reporting, maintaining high standards for accuracy and compliance . + Manage pharmacometrics projects, including non-compartmental PK analyses, PK/PD… more
- Deloitte (Boston, MA)
- …case dispositions + Holding meetings with Project Leadership to discuss investigator performance, issue management, and case escalation decisions + Providing ... + 4+ Years Experience in managing a team of professional AML/OFAC compliance practitioners + 4+ Years Experience drafting Suspicious Activity Reports ("SARs") +… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** About the role: The Senior Medical Science Liaison is a field-based, external customer-facing member of the US ... with facilitation of strategically aligned medical collaborative studies and investigator -initiated research processes * Display advanced knowledge of therapeutic… more
- Merck (Boston, MA)
- …of local data generation study concepts and protocols. + Reviews Investigator -Initiated Study proposals from key countries prior to headquarters submission (ex-USA). ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents… more
- Dana-Farber Cancer Institute (Boston, MA)
- …trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Trials Office. The Clinical Research Manager, in collaboration ... research activities (therapeutic and non-therapeutic), all related regulatory and compliance oversight, and direct supervision of their program's clinical research… more
- Sumitomo Pharma (Boston, MA)
- …evaluation reports according to established safety governance policies and keeping senior leadership informed of safety issues. **Job Duties and Responsibilities** + ... Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigator 's Brochures (IB), Investigator communications (Dear Health Care Provider… more
- Bausch + Lomb (Boston, MA)
- …ensure study objectives are being met and provide the operations director and/or senior management with timely updates on progress and changes in scope, schedule, ... and resources. + Organize investigator and expert meetings relevant to the indication and...management (including site monitoring), scientific methods, research design, regulatory compliance , and clinical data management. + Minimum 10-12 years… more
- Beth Israel Lahey Health (Boston, MA)
- **Overview** **The Senior Research Administrator, Post-Award (Research Administrator II)** will, under the direction of the Director, Major Projects and Post Award ... sponsored research post-award portfolio including oversight and management of financial policy, compliance and reporting issues that arise during the life of the… more
- Merck (Boston, MA)
- …andexpectations. Participate and support the goals and objectives of the GCTO Senior LeadershipTeam (SLT) or extended Leadership Team (eLT). Speak with "one voice" ... Region, Regional Country andCluster Directors, and their respective staff. Ensure that compliance , quality and timelineobjectives are met for all trials executed in… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Medical Affairs Company Sponsored Studies (MACS) collaborative studies and Investigator Initiated Research (IIR). Specific objectives include: + Partners with ... on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making, monitoring slippage and developing strategies… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the Global Medical budget for nephrology TA. + Acts as a senior company representative interacting with external scientific leaders, patient advocacy groups and/or ... patient organizations, and expert HCPs. + Collaborates with Legal, Ethics, Compliance and Regulatory functions to ensure appropriate interactions between Global… more