- Commonwealth Care Alliance (Boston, MA)
- …the integrity, accuracy, and timeliness of data used for encounter submissions , risk scoring, and revenue optimization. The Developer will work cross-functionally ... data pipelines and systems to support risk adjustment and encounter data submissions (RAPS/EDPS). + Implement and optimize SQL scripts, stored procedures, and ETL… more
- Actalent (Cambridge, MA)
- …statistical deliverables for clinical trials and contribute to Health Authority submissions . Responsibilities + Contribute statistical expertise to the design and ... + Carry out functional responsibilities in accordance with company guidelines and regulatory requirements. Essential Skills + Master's or Doctorate (Ph.D.) degree in… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Oversee and/or facilitate cross-functional review of internal/external study submissions . + Process review committee materials including study concepts and ... per Medical Affairs SOPs and processes. + Coordinate with Pharmacovigilance, Quality and Regulatory Affairs to respond to external audits and requests from external … more
- Fenway Health (Boston, MA)
- …+ Regulatory Compliance:Assist with all Institutional Review Board (IRB) submissions concerning protocol changes and annual reviews. Prepare and submit these ... Investigator or research scientist, ensuring adherence to ethical and regulatory standards. + Meeting Participation:Attend all regularly scheduled research meetings,… more
- Sanofi Group (Cambridge, MA)
- …structure of the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP Supports registrations, label submissions and modifications ... development strategies for research projects + Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project… more
- Takeda Pharmaceuticals (Boston, MA)
- …scientific communications materials such as slide decks, NCCN or pathway submissions , animations, and digital amplification of data; manages vendors, freelancers, ... and publication planning, including ideas for sub-analyses + **Compliance and Regulatory :** Excellent understanding of regulatory , compliance and legal… more
- Takeda Pharmaceuticals (Boston, MA)
- …Access, Global Evidence and Outcomes, Medica Affairs, Clinical Development, Regulatory Affairs, Biostatistics, Global Emerging Markets (GEM; eg, China), Project ... Global Evidence and Outcomes, Medical Affairs, Clinical Science, Legal, Regulatory + OBU 10, EUCAN, GEM **Minimum Qualifications/Requirements:** + Advanced… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …stakeholders across the organization to provide compliance oversight of sponsored submissions . The AD Post-Award will organize and recommend training sessions, ... with internal and external stakeholders, including faculty, staff, sponsors, and regulatory agencies. + Represent the post-award team in meetings and committees… more
- Dana-Farber Cancer Institute (Boston, MA)
- …collection of necessary documentation and finalization of references for journal submissions . Additionally, the role involves creating visual content for grants and ... facilitating successful collaboration across various levels of an organization. + Regulatory Expertise: Strong knowledge of regulatory affairs, research ethics,… more
- WIN Waste Innovations (Brockton, MA)
- …each assigned site with administrative environmental and safety systems, reports, and submissions . What You'll Do Training and Meetings + Implement safety and ... open environmental compliance and safety issues, requests for information, regulatory interpretations, change management, etc. + Participate in school programs,… more
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