- ThermoFisher Scientific (Waltham, MA)
- … clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy ... working in a range of document management systems would be preferred. As a remote -based Document Review Specialist within the FSP Team, you will effectively … more
- Bristol Myers Squibb (Devens, MA)
- …M-F, Standard Working Hours **Responsibilities:** + Coordinate and prepare for Material Review Board (MRB) meetings by: + Monitoring quality events and ... our Cell Therapy team. The **Senior Manager, QA Material Review Board** role is responsible for the Material ...for MRB. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in… more
- Takeda Pharmaceuticals (Boston, MA)
- …and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI ... support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc. Escalation Process… more
- Takeda Pharmaceuticals (Boston, MA)
- …and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, ... + Analyze and interpret safety data from various sources including non- clinical , clinical , post-marketing and scientific literature. + Conduct signal… more
- IQVIA (Boston, MA)
- **Position Overview:** IQVIA is seeking an experienced Associate Clinical Project Management Director/Trial Delivery Manager (TDM) to lead and coordinate global and ... regional clinical trial management activities. This role ensures the successful...interfacing with internal and external stakeholders to ensure compliance, quality , and timely delivery of trial milestones. **Key Responsibilities:**… more
- Insight Global (Boston, MA)
- …with utilization review , ideally experience with public programming, and excellent clinical judgment. This position is 100% remote but must have active ... within the Operations organization. This position will fall within the Clinical Performance, Operations, and Innovation organization. The UM Director is responsible… more
- Beth Israel Lahey Health (Lynnfield, MA)
- …flexible and adaptable, capable of working independently, engaging effectively with clinical teams, and committed to delivering high- quality patient care. ... three years of primary care experience to support clinicians and practices on clinical Epic in-basket management. This position can be mainly or completely remote… more
- Takeda Pharmaceuticals (Boston, MA)
- …drives strategy of Takeda's global data standards, processes and technologies across the clinical data continuum for quality of deliverables and global data ... you to shine? Join us as a Senior Director, Clinical Data Standards based remotely reporting to the Vice...vendor/CROs for utilization of Takeda standards. + Conducts ongoing review and development of metrics to assess standards utilization… more
- Prime Therapeutics (Boston, MA)
- …of pharmacy with us. **Job Posting Title** Regulatory Analyst Sr - Remote **Job Description** The Senior Regulatory Analyst is responsible for leading portions ... of departmental regulatory review and analysis, external audits and accreditation processes, and...business partners with regard to related regulatory activity and quality efforts involving utilization and/or medication therapy management, network… more
- Charles River Laboratories (Wilmington, MA)
- …employee handbooks, compensation and benefits issues, etc. Draft, negotiate and review documents relating to executive employment, as well as general HR-related ... the company. Provide general legal support, when appropriate. **Position is remote and will require occasional domestic and international travel. Essential Duties… more