- Takeda Pharmaceutical (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide.Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you will be responsible ... and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI… more
- HealthCare Support (Boston, MA)
- …relevant screenings within assigned territory as scheduled to capture members' clinical needs and meet regulatory requirements. Medication reconciliation, ... as needed, including relevant behavioral health screeners (PHQ-9, EASI, Audit, DAST). Uses clinical judgment to escalate members with urgent needs to the Regional RN… more
- Dana-Farber Cancer Institute (Brookline, MA)
- The Program Manager I is responsible for the execution and management of programs that contribute to departmental or cross-departmental objectives. This role ... coordinating timelines, and ensuring effective communication among team members. The Program Manager will work closely with stakeholders to facilitate… more
- Beth Israel Lahey Health (Boston, MA)
- …just taking a job, you're making a difference in people's lives.** Job Summary: The Regulatory and Accreditation Program Manager reports to the Director, ... Regulatory Affairs. Manages the accreditation/ regulatory program requirements related to the Joint...requirements to identified members of the BIDMC community and clinical affiliates. This position supports the BIDMC Transparency agenda… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you will be responsible ... and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI… more
- Tufts Medicine (Burlington, MA)
- …disabilities, obesity, behavioral health, etc.). Additionally, manages patient registries for each program to track the clinical care and outcomes of individuals ... academic and research structure. Tufts Medicine is comprised of the following clinical entities: . Tufts Medicine Professional Group (TMPG) . Tufts Medicine… more
- ConvaTec (Lexington, MA)
- …(LSE:CTEC). To learn more please visit http://www.convatecgroup.com **Position Overview:** The Sr. Manager , Clinical Operations plays a key role to the success ... of Convatec's clinical trials. The Sr. Manager , ...cross functional team members including, but not limited to, regulatory , R&D, project/ program management, data management, and… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …sponsor requirements. The Manager collaborates with investigators, research teams, and regulatory staff to maintain the integrity of clinical trial data and ... England state (ME, VT, NH, MA, CT, RI).** The Manager , Clinical Trials Registry is responsible for... trial reporting. + Generate reports and metrics on clinical trial registration compliance for leadership and regulatory… more
- Pfizer (Cambridge, MA)
- …or supports other critical documents, eg, protocol amendments, investigator brochure, and regulatory documents. + Collaborate with Clinical Operations to ensure ... regarding strategy and/or data, and may assist with authoring clinical sections of regulatory documents (IB, Annual...results. + While generally not serve in an official manager role, may review the work of others within… more
- J&J Family of Companies (Danvers, MA)
- …**You will be responsible for** **:** + Actively engages and collaborates with Clinical Program /Project Managers, Clinical Affairs Leadership, and other ... **We are searching for the best talent for a** Manager , Global Clinical Compliance. This is a...risk-based quality driven strategies to identify, measure, and mitigate clinical study risks that are aligned with regulatory… more
- Fresenius Medical Center (Lowell, MA)
- …the delivery of maximum quality care to all patients. + Must complete Clinical Manager training modules and ongoing developmental programs within the specified ... core values and customer service philosophy. Adheres to the FMCNA Compliance Program , including following all regulatory and FMS policy requirements. Ensure… more
- ThermoFisher Scientific (Cambridge, MA)
- …This candidate must have strong Project Management skills + Must understand pre- clinical drug development activities, CMC, regulatory and commercial activities + ... **Environmental Conditions** Office **Job Description** **AD Project Management/Senior Project Manager , Drug Development** At Thermo Fisher Scientific, you'll discover… more
- Rhythm Pharmaceuticals (Boston, MA)
- …of junior team members + Prepare budgets, timelines, and forecasts for assigned clinical studies + Interface with Finance, Program Management, Accounting, Supply ... company + Experience working on Phase I - IV multinational clinical studies + Regulatory knowledge, including Good Clinical Practices (GCPs) + Knowledge… more
- Medtronic (Boston, MA)
- …+ Recommends changes to labeling, manufacturing processes, marketing materials, and clinical protocols to ensure regulatory compliance. + Monitor, evaluate, ... of medical device classifications and technologies. + Demonstrated expertise in developing regulatory strategies that support timely approval of clinical trial… more
- Medtronic (Boston, MA)
- …Body as required. + Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. + Maintain accurate and up-to-date ... pain, restore health, and extend life for patients around the world. As a Regulatory Affairs Specialist, you will play a vital role in supporting ongoing product… more
- Lilly (Boston, MA)
- …and program directors + Global brand and product planning teams + Clinical development and research staff + Regulatory , legal, and safety teams **External ... studies, and outcomes and pharmacoeconomic research. The TA program phase CRS is aware of and ensures that...clinical experts + Investigators and practicing clinicians + Regulatory agencies + Professional associations + Advocacy and community… more
- East Boston Neighborhood Health Center (Revere, MA)
- …Director, Clinical Director, Operations Director) to ensure that the Program meets regulatory requirements for data integrity, data-driven performance ... of PACE Quality Team. Leveraging a strong foundation in clinical pharmacy, this role integrates regulatory knowledge...CLINICAL QUALITY AND PERFORMANCE IMPROVEMENT + Oversees QI Program in collaboration with the PACE Senior Management Team… more
- Bristol Myers Squibb (Cambridge, MA)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . Position: Manager , Business Analyst, In-Vivo & Non- Clinical Safety Product Team, ... us and make a difference. Position Overview: The Business Analyst in the In-Vivo & Non- Clinical Safety Product Team will play a key role in bridging the gap between… more
- Commonwealth Care Alliance (Boston, MA)
- …and relevant screenings within assigned territory as scheduled to capture members' clinical needs and meet regulatory requirements. + Medication reconciliation, ... behavioral health screeners (PHQ-9, EASI, Audit, DAST). + Uses clinical judgment to escalate members with urgent needs to...with urgent needs to the Regional RN Supervisor and/or manager during or immediately following the visit. + Utilize… more
- Amergis (Boston, MA)
- …and relevant screenings within assigned territory as scheduled to capture members' clinical needs and meet regulatory requirements. + Medication reconciliation, ... RN with Oasis, MDR, and/or homecare experience to provide clinical assessments in residential and community settings in Boston....with urgent needs to the Regional RN Supervisor and/or manager during or immediately following the visit. + Utilize… more
