- Sanofi Group (Cambridge, MA)
- **Job Title:** Periodic Reports Expert **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The race ... CFR etc) and process owners for the authoring global periodic safety reports (PSRs) coordinated by Global...delays + Fluency in ICH and GVP guidelines regarding periodic safety report content + Comfortable leading… more
- Sanofi Group (Cambridge, MA)
- …Report , Periodic Safety Update Report + Serve as the medical safety expert to the GPE Periodic Reports group for assigned projects and products. ... Response to health authority question/request for information, Core Safety Information updates, periodic reports ** Report Writing:** + Document, coordinate,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …PM to track progress against strategic plans, including the development + communication of periodic reports . + Implement and advocate for the use of AI-powered ... As part of the US Medical team, you will report to the Senior Director, US Medical Head -...of accountability, the role serves as a Subject Matter Expert (SME), representing the USMA at the Global level… more
- Lilly (Boston, MA)
- …assist in the preparation of regulatory reports , including INDs, FDA annual reports , regulatory responses and Periodic Adverse Drug Experience Reports ... leadership to a rapidly expanding cardio-renal portfolio. The Executive Director will report to the Senior Vice President of Cardio-Renal Research and Early Clinical… more
- Beth Israel Lahey Health (Cambridge, MA)
- …submission process by reviewing charts in the EMR, reviewing outliers, compiling reports and serving as the liaison with clinical stakeholder and clinical committees ... data for reporting quality measures, including both concurrent medical record review and periodic medical record review for audit purposes as well as medical record… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Evaluation Reports (CER), Summary of Safety & Clinical Performance (SSCP) and Periodic Safety Update Report (PSUR) is expected as well as providing input ... health leadership competencies and management proficiencies to effectively deliver expert medical guidance to the Gastroenterology business. Fundamental competencies… more
- GE HealthCare (MA)
- …adverse events. + Support **Risk Evaluation and Mitigation Strategies (REMS)** and ** Periodic Benefit-Risk Evaluation Reports (PBRERs)** . + Responsible for ... The Responsible person for PV US & CAN will report to Head of Global Pharmacovigilance and Drug Safety...processes in compliance with regulatory requirements. + Be the expert and face of Drug Safety and PV in… more
- Mastercard (Boston, MA)
- …Supply Chain, Sourcing, and TPRM programs. Enable business strategy through providing expert guidance on the legal and regulatory environment and risks. Foster a ... disputes related to privacy, data protection, AI and cyber laws. Provide expert guidance on third-party supplier clauses during contract negotiations to mitigate… more
- Commonwealth Care Alliance (Boston, MA)
- …all nursing (RN, LPN) and MA roles in the practice. 10 - 15 direct reports across multiple sites. Will require periodic travel to Springfield and Worcester ... a defined panel of complex patients * Subject matter expert for clinical and care coordination needs. * Evaluate...licensure. * Reporting and data management as needed for reports and areas of oversite. Working Conditions: * This… more
- Medtronic (Boston, MA)
- …and competent authority engagements, including but not exclusive to: o Post-Market Surveillance Report (PMSR), Periodic Safety Update Report (PSUR), Clinical ... duties may be assigned. . Serves as Subject Matter Expert for Risk Management across the Post-Market space for...Files readiness for post-market. Including review of Risk Management Report (RMR) and Post-Market Surveillance Plan (PMSP). . Supports… more
- FM (Waltham, MA)
- …- US, International and Global. The incumbent will also be leading periodic investments, economic and financial markets-related projects and initiatives related to ... The role will have people management responsibilities, with junior and/or mid-level direct reports for different equities buckets as necessary and will rely on the… more
- FM (Waltham, MA)
- …- US, International and Global. The incumbent will also be leading periodic investments, economic and financial markets-related projects and initiatives related to ... will have people management responsibilities, with junior and/or mid-level direct reports for investment diligence purposes, and/or different equities buckets as… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …track progress against strategic plans, including development + communication of periodic reports . **Develop US Product Medical Strategy:** + ... role within the US Medical Affairs (USMA) organization that reports to the Vice President US Medical, Dermatology and...Medical Unit. You will serve as a Subject Matter Expert (SME), representing the USMA on relevant internal committees… more
- State of Massachusetts (Maynard, MA)
- …clothes, weapons, sexual assault kits), perform Y-screening when applicable, b. Prepare reports on laboratory tests and, c. Communicate results to the customer. 3. ... documenting contact with case-related items and materials. 8. Provide testimony as an expert and/or material witness in court and/or at formal judicial hearings to… more
- Guardian Life (Pittsfield, MA)
- …interpersonal effectiveness, ability to demonstrate business savvy, being a subject matter expert , all while supporting the Law Department's Mission to be a trusted ... fraud through the review of automated alert scenarios and manual exception reports and timely escalate concerns for further investigation. + Collaborates with… more
- Beth Israel Lahey Health (Burlington, MA)
- …well as acting as a team lead resolving issues and triaging problems, an EPIC expert , a mentor/preceptor to other MAs as well as assisting the practice with special ... of the MA rooming standards. Documents data in EHR. Reports findings as needed to provider. Using the Pended...provider. + Administrative Support + Provides back up or periodic administrative assistance to the practice as needed, including… more
- State of Massachusetts (Boston, MA)
- …be approved for use in Massachusetts. The Executive Director ("ED") for the Unit reports to the Associate Deputy Commissioner of Policy & Boards ("ADC"). At the ... efforts by reviewing the content of investigative files and inspection reports and makes decisions and recommendations regarding their disposition. The ED… more
- WATTS (North Andover, MA)
- …dynamic future ahead. As a Senior Product Engineer, you will be a technical expert for a Watts strategic product category and lead the new product development ... Responsible for accurate project documentation and preparation of comprehensive technical reports and presentations to support product launches, updates, and lessons… more
- Securitas Security Services USA, Inc. (North Reading, MA)
- …a Criminal Justice major eager to gain hands-on experience? A customer service expert seeking a rewarding career change? Or perhaps a recent college graduate ready ... off client site. **Typical Job Duties:** + Observes and reports activities and incidents at an assigned client site,...and safety of client property and personnel. + Makes periodic patrols to check for irregularities and to inspect… more
- Takeda Pharmaceuticals (Lexington, MA)
- …care professionals (HCPs) and consumers. As part of the US Medical team, you will report to the Director, US Medical Information and Review. This is a hybrid role ... including Clinical Dossiers, Letters and Frequently Asked Questions (FAQs), and periodic review of inquiries and responses. + Provide advanced medical information… more