- Takeda Pharmaceutical Company Limited (Boston, MA)
- …is true to the best of my knowledge. Job Description Senior Scientific Director, Clinical Pharmacology Boston, MA OBJECTIVES/PURPOSE The Plasma-Derived Therapies ... execution and reporting, maintaining high standards for accuracy and compliance . Manage pharmacometrics projects, including non-compartmental PK analyses, PK/PD… 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
- CenterWell (Boston, MA)
- …waste, and abuse (FWA), ensuring accuracy, appropriate contract interpretation, and compliance with established policies and procedures. This role gathers and ... reports and presenting case outcomes and making recommendations to senior leadership. Responsibilities include initiating, coordinating, and reviewing audits of… 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
- J&J Family of Companies (Boston, MA)
- …therapeutic areas and providing research support for company as well as investigator -initiated studies. The Senior Medical Science Liaison will: * Develop ... of America **Job Description:** Johnson & Johnson Innovative Medicines is recruiting for a Senior Medical Science Liaison - Solid Tumor Oncology to be based in the… 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
- ICON Clinical Research (Boston, MA)
- As a Senior CRA (ONC) you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Roles and ... in site feasibility and/or pre-trial site assessment visits. + Attends/participates in investigator meetings as needed. + May serve as Lead CSM for specific… 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
- WuXi AppTec (Natick, MA)
- …review as SOP and protocol required + Function as a Principle Investigator , responsible for pathology-related activities + Conduct planned, long-term education and ... consultation to Study Directors on studies. + Ensure the compliance of various GLPs, comply protocol and SOPs during...Responsible for conducting toxicology and medical device studies in compliance with GLP/CNAS + Perform other duties as assigned… 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
- 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
- Beth Israel Lahey Health (Boston, MA)
- **Overview** Under general direction, the ** Senior Research Administrator (Research Administrator II)** , provides Pre and Post award support to Joslin investigators ... trials. Post-award responsibilities involve the administration of research projects in compliance with legal, sponsor and Center policies and regulations. This… more
- Merck (Boston, MA)
- …identifying areas of high impact and translating into messaging that resonates with senior leadership. + Develop and assess team data and analytics via KPI ... information to internal and external stakeholders at all levels (eg, senior leadership, management and individual contributor) and create presentation concepts and… more
